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Biomedical subjects

E E Hodge

Publications and source records attributed to E E Hodge.

At least 19 recordsLinked to original sources
PubMed2005

A multicenter analysis of the significance of HLA matching on outcomes after kidney-pancreas transplantation.

The purpose of this study was to determine the influence of HLA matching on outcomes in simultaneous kidney-pancreas transplant (SKPT) recipients in a multicenter trial. From March 1999 to May 2001, a total of 297 SKPT recipients were enrolled in a prospective randomized trial of 2 daclizumab dosing strategies versus no antibody induction in combination with tacrolimus, mycophenolate mofetil, and steroids in SKPT recipients. Subanalyses using both univariate and multivariate models were performed at 1 year to identify factors associated with acute rejection, graft loss, or death. Potential risk factors evaluated were treatment group, African American ethnicity, HLA-A mismatches (MM), HLA-B MM, HLA-DR MM, total HLA MM, surgical technique, cytomegalovirus status of donor and recipient, and delayed graft function (DGF). Univariate analyses revealed that treatment group, HLA-A MM, HLA-B MM, total HLA MM >3, and DGF were significantly associated with acute rejection. These variables were then entered into logistic and Cox regression analyses. HLA-A MM and DGF were the only variables that remained significantly associated with acute rejection in the multivariate model. The relative risk for acute rejection in recipients with HLA-A MM was 1.56 (P = .02). In conclusion, despite contemporary immunosuppression, the degree of HLA MM, particularly HLA-A, and DGF are associated with an increased risk for acute rejection in SKPT recipients at 1 year. Less rejection was noted in patients with 0 MM at all 3 HLA loci and in patients with total HLA-MM <3. However, none of these factors affected short-term patient or graft survival rates.

Antibodies, Monoclonal↗
PubMed2005

A prospective, randomized, multicenter study evaluating the safety and efficacy of two dosing regimens of daclizumab compared to no antibody induction in simultaneous kidney-pancreas transplantation: results at 3 years.

UNLABELLED: This is a report of outcomes at 36 months of a prospective, multicenter study comparing the safety and efficacy of two dosing regimens of daclizumab with no antibody induction in simultaneous kidney-pancreas transplant (SKPT) patients receiving tacrolimus, mycophenolate mofetil, and prednisone. A total of 298 SKPT patients were randomized into one of three groups: daclizumab 1 mg/kg/dose every 14 days for 5 doses (group 1, n = 107); daclizumab 2 mg/kg/dose for 2 doses (group 2, n = 113); and no antibody induction (group 3, n = 78). There were no differences in baseline characteristics among the three groups, and results were analyzed by an intent-to-treat analysis. The incidence of composite events (acute rejection [AR], any allograft lost, or death) at 3 years was 49%, 43%, and 55% in groups 1, 2, and 3, respectively (P = .278). The cumulative incidences of AR were not statistically different among the three groups (P = .178). The mean time to first AR was delayed in groups 2 (288 days) and 1 (245 days) compared to group 3 (145 days, P = .07). There were no differences in patient or allograft survival rates among the three groups, and the rates of serious adverse events, infections, and hospital readmissions were also comparable. Excellent dual graft function in patients with surviving grafts was observed in all three groups at 3 years. CONCLUSIONS: The alternative 2-dose regimen of daclizumab was as safe and effective as the conventional 5-dose regimen compared to no antibody induction in SKPT patients, but no long-term benefits were noted.

Acute Disease↗
PubMed2005

Risk factors and outcomes analyses at 36 months of a prospective, randomized, multicenter, trial of daclizumab induction in simultaneous kidney-pancreas transplant recipients.

UNLABELLED: The purpose of this study was to analyze risk factors for acute rejection (AR) and long-term outcomes in simultaneous kidney-pancreas transplant (SKPT) patients enrolled in a prospective, multicenter study of daclizumab (DAC) versus no antibody induction. METHODS: A total of 298 SKPT patients were randomized into three groups and categorized based on an intent to treat analysis, and factors associated with AR and survival were identified using logistic regression and Cox proportional hazards models. RESULTS: There were no differences in patient or allograft survival or rejection rates among the three groups at 36 months follow-up. Delayed (kidney) graft function (DGF) was a risk factor for subsequent kidney AR (odds ratio = 2.79, P = .002). The presence of kidney AR was also a risk factor (hazard ratio [HR] = 3.1, P = .003) for kidney graft loss, whereas risk factors for pancreas graft loss (censored for graft loss within 30 days or death with functioning graft) included pancreas AR (HR = 1.97, P = .012), kidney AR (HR = 1.61, P = .042), CMV serostatus donor +/recipient - (HR = 1.62, P = .026), and HLA-B mismatch (HR = 1.58, P = .01). Kidney graft loss (HR = 5.5, P = .02) was the only predictor of mortality. CONCLUSIONS: At 36 months, no significant differences in outcomes were noted in the three study groups. DGF was the major risk factor for kidney AR, kidney AR was the major risk factor for kidney graft loss, and kidney graft loss was the major determinant of mortality. Prevention of kidney DGF and AR in SKPT recipients may play a pivotal role in optimizing long-term outcomes.

Antibodies, Monoclonal↗
PubMed2004

African-American ethnicity is no longer a risk factor for early adverse outcomes in simultaneous kidney-pancreas transplantation with contemporary immunosuppression.

The influence of ethnicity on the outcome of simultaneous kidney-pancreas transplantation (SKPT) is controversial. The aim of this study was to determine the impact of ethnicity on the major endpoints of a prospective, multicenter, randomized trial of two dosing regimens of daclizumab compared to no-antibody induction in SKPT. A total of 297 patients were randomized into three groups: daclizumab 1 mg/kg/dose every 14 days for five doses (group I, n = 107); daclizumab 2 mg/kg/dose every 14 days for two doses (group II, n = 112), and no-antibody induction (group III, n = 78). All patients received tacrolimus, mycophenolate mofetil, and steroids for maintenance immunosuppression. Thirty-seven patients (12.5%) were African-American (AA) and 260 were non-African-American (NAA). Demographics and transplant characteristics were comparable between AA and NAA patients. At 1 year, no differences were seen in patient survival (97% AA, 96% NAA), kidney graft survival (94% AA, 93% NAA), and pancreas graft survival (84% AA, 85% NAA). Rejection rate and incidence of adverse events were similar between AA and NAA subjects. Kidney graft function was comparable between AA and NAA patients at 1 year; however, mean HgbA1C was higher, C-peptide was lower, and oral hypoglycemic use was more common in AA subjects. Thus, in this prospective multicenter study, AA ethnicity was not associated with an increased risk of early adverse outcomes in SKPT. Follow-up will be required to determine whether long-term outcomes remain equivalent, particularly with regard to pancreas graft function.

Adult↗
PubMed2004

Does surgical technique influence outcomes after simultaneous kidney-pancreas transplantation?

Since 1995, many centers have switched from bladder to enteric drainage of the exocrine secretions in simultaneous kidney-pancreas transplantation (SKPT). Enteric exocrine drainage may be performed with either systemic (systemic-enteric [S-E]) or portal (portal-enteric [P-E]) venous delivery of insulin. Controversy exists regarding the optimal surgical technique. From March 1999 to May 2001, a total of 297 SKPT patients were enrolled into a prospective, multicenter, randomized, open-label, comparative trial of two daclizumab dosing strategies versus no-antibody induction in combination with tacrolimus, mycophenolate mofetil, and steroids in SKPT recipients. Surgical techniques were center specific. A total of 171 patients (58%) underwent SKPT with S-E drainage, 96 (32%) with P-E drainage, and 30 (10%) with systemic-bladder (S-B) drainage. The two groups randomized to daclizumab induction were similar with regard to surgical technique (64% S-E, 25% P-E, 11% S-B drainage). Demographic and transplant characteristics and immunosuppression were similar among the three groups, except that more patients with P-E drainage did not receive antibody induction. At 6 months, no differences were seen in patient and graft survival rates, surgical complications including pancreas thrombosis, rates of rejection or infection, readmissions, and kidney and pancreas allograft function among the three different surgical techniques. The 6-month results of this multicenter study suggest no significant differences in outcomes in SKPT recipients according to surgical technique.

Antibodies, Monoclonal↗
PubMed2004

The impact of delayed graft function of the kidney on the pancreas allograft in simultaneous kidney-pancreas transplantation.

UNLABELLED: It is unclear whether delayed graft function (DGF) of the kidney has any influence on pancreas graft function following simultaneous kidney-pancreas transplantation (SKPT). A subgroup analysis was conducted using data from a multicenter study to determine the impact of DGF of the kidney on pancreas graft function following SKPT. METHODS: Of the 297 SKPT patients, 24 (8%) had DGF of the kidney, defined as the need for dialysis during the first week posttransplant. Clinical parameters including patient and graft survival, incidence of acute rejection, and pancreas and renal function were compared between patients with and without DGF at 1 week, and at 1, 3, 6, and 12 months posttransplant. RESULTS: Demographic and transplant characteristics were similar between the two groups except for longer kidney and pancreas cold ischemia times, more males, and more primary cytomegalovirus (CMV) exposure in the DGF group (P <.05). No differences were seen in patient and graft survival rates, but the incidence of acute renal rejection was higher in patients with DGF (42%) than in those without DGF (15%, P =.001). More patients with DGF (25%) received oral hypoglycemic agents at 1-year posttransplant than in those without DGF (5%, P <.01). At 1 year, the mean serum creatinine was 1.8 mg/dL and 1.4 mg/dL in patients with and without DGF, respectively (P <.01). CONCLUSIONS: Patients with DGF of the kidney had a higher incidence of acute renal rejection and received oral hypoglycemic agents more often during the first year posttransplant compared to those who did not have DGF following SKPT.

Cytomegalovirus Infections↗
PubMed2004

Effect of donor-recipient cytomegalovirus serologic status on outcomes in simultaneous kidney-pancreas transplant recipients.

Diabetic patients undergoing simultaneous kidney-pancreas transplantation (SKPT) may be at high risk for developing cytomegalovirus (CMV) infection. To study this issue, we analyzed 297 SKPT patients enrolled into a multicenter trial of two daclizumab dosing strategies versus no antibody induction in combination with tacrolimus, mycophenolate mofetil, and steroids. Complete donor (D) and recipient (R) CMV serology values were available in 294 cases and were distributed as follows: 86 (29%) D+/R-. Eighty-six (29%) D+R+; 45 (16%) D-/R+; 77 (26%) D-/R-; CMV antiviral prophylaxis was center specific, but 98% of patients received either ganciclovir or acyclovir. No differences existed in demographic or transplant characteristics or immunosuppressive regimens among the four groups except that more African-American SKPT recipients were CMV positive at transplant (P <.001). At 6 months, no differences were seen in patient and graft survival rates (GSR) and the incidence of acute rejection (AR) among the groups. However, the CMV D+/R- group had a significantly higher incidence of CMV infection/disease (14%) than the other groups collectively (4%, P <.05). Most cases of CMV infection/disease occurred greater than 3 months posttransplant when prophylaxis was discontinued. In the D-/R- group, the pancreas GSR was higher (94% vs 86% in the remaining three groups) and the incidence of AR was lower (16% vs 25% in the remaining three groups, both P =.09). Primary CMV exposure remains a major risk factor for CMV infection/disease, but does not have an adverse impact on short-term outcomes. Conversely, protective CMV seronegative matching may have a beneficial effect on outcomes.

Cytomegalovirus Infections↗
PubMed2004

One-year outcomes in simultaneous kidney-pancreas transplant recipients receiving an alternative dosing regimen of daclizumab.

UNLABELLED: The purpose of this study was to compare the safety and efficacy of two dosing regimen of daclizumab with no-antibody induction in simultaneous kidney-pancreas transplant (SKPT) recipients receiving tacrolimus, mycophenolate mofetil, and steroids. METHODS: A total of 297 SKPT patients were enrolled into this prospective, multicenter, randomized, open-label study. The patients were randomized into three groups: daclizumab 1 mg/kg/dose every 14 days for five doses (group I, n = 107), daclizumab 2 mg/kg/dose every 14 days for two doses (group II, n = 112), and no-antibody induction (group III, n = 78). RESULTS: There were no differences in baseline characteristics among the three groups, except for a higher proportion of African-Americans in group II. The incidence of composite events (acute rejection, graft loss, or death) at 1 year was 36.4%, 32.7%, and 48.7% for groups I, II, and III, respectively (P <.05, group II vs group III). The incidence of acute rejection was highest in group III (34.6%) compared to groups I and II (22.4% and 22.1%, respectively, P <.05). The mean time to acute rejection was delayed in group II (96 days) compared to 23 days in group I and 20 days in group III (P <.05). The adverse-event profiles were comparable among the three groups, except for a higher incidence of infection and readmissions in group III. CONCLUSIONS: Daclizumab was safe and effective in reducing the incidence of acute rejection when compared to no induction. The alternative two-dose regimen of daclizumab was as effective as the conventional five-dose regimen and is logistically more desirable.

Antibodies, Monoclonal↗
PubMed2000

Laparoscopic lymphocelectomy: a multi-institutional analysis.

PURPOSE: Because symptomatic lymphoceles are infrequent, single center studies generally report small numbers of patients. We report a multi-institutional experience with and long-term outcome following laparoscopic lymphocelectomy in 81 patients. MATERIALS AND METHODS: Data were obtained from 9 institutions at which at least 5 cases of laparoscopic lymphocelectomy had been performed. Baseline patient demographics, operative time and blood loss, special operative adjunct techniques, postoperative course, convalescence, complications and lymphocele recurrence data were collected and analyzed. RESULTS: A total of 56 men and 25 women with a mean age of 41 years were included in the study. Lymphocele formed after renal transplantation in 78 patients (96%) and after pelvic lymph node dissection in 3 (4%). Average operating time was 123 minutes with a mean blood loss of 43 ml. Omentopexy was performed in 11 cases (13.6%). No intraoperative stenting of the transplant ureter was performed. Intraoperative complications consisted of laryngospasm, bladder injury, inferior epigastric artery injury and mild renal capsule hematoma in 1 patient each. Conversion to open surgery was required for repair of bladder injury in 1, repair of preexisting hernia in 1, unusually thickened lymphocele wall in 1 and inaccessible lymphocele location in 4 cases. Mean time to ambulation and resumption of regular diet was 1 day, and mean hospital stay was 1.5 days. Postoperative complications included trocar site hernia in 1 and urinary retention in 2. Convalescence averaged 2.5 weeks. During a mean followup of 27 months 5 patients (6%) had lymphocele recurrence. CONCLUSIONS: Laparoscopic lymphocelectomy is safe, minimally invasive and effective. It is an excellent alternative to the conventional open surgical approach.

Adult↗
PubMed1998

Results of the double-blind, randomized, multicenter, phase III clinical trial of Thymoglobulin versus Atgam in the treatment of acute graft rejection episodes after renal transplantation.

BACKGROUND: Thymoglobulin, a rabbit anti-human thymocyte globulin, was compared with Atgam, a horse anti-human thymocyte globulin for the treatment of acute rejection after renal transplantation. METHODS: A multicenter, double-blind, randomized trial with enrollment stratification based on standardized histology (Banff grading) was conducted. Subjects received 7-14 days of Thymoglobulin (1.5 mg/kg/ day) or Atgam (15 mg/kg/day). The primary end point was rejection reversal (return of serum creatinine level to or below the day 0 baseline value). RESULTS: A total of 163 patients were enrolled at 25 transplant centers in the United States. No differences in demographics or transplant characteristics were noted. Intent-to-treat analysis demonstrated that Thymoglobulin had a higher rejection reversal rate than Atgam (88% versus 76%, P=0.027, primary end point). Day 30 graft survival rates (Thymoglobulin 94% and Atgam 90%, P=0.17), day 30 serum creatinine levels as a percentage of baseline (Thymoglobulin 72% and Atgam 80%; P=0.43), and improvement in posttreatment biopsy results (Thymoglobulin 65% and Atgam 50%; P=0.15) were not statistically different. T-cell depletion was maintained more effectively with Thymoglobulin than Atgam both at the end of therapy (P=0.001) and at day 30 (P=0.016). Recurrent rejection, at 90 days after therapy, occurred less frequently with Thymoglobulin (17%) versus Atgam (36%) (P=0.011). A similar incidence of adverse events, post-therapy infections, and 1-year patient and graft survival rates were observed with both treatments. CONCLUSIONS: Thymoglobulin was found to be superior to Atgam in reversing acute rejection and preventing recurrent rejection after therapy in renal transplant recipients.

Acute Disease↗
PubMed1998

Prostate cancer in the post-transplant population. Urologic Society for Transplantation and Vascular Surgery.

OBJECTIVES: We conducted a multicenter retrospective study to determine the results of treatment for prostate cancer in solid organ transplant recipients. METHODS: A retrospective analysis of all patients diagnosed with prostate cancer after organ transplantation at five centers was conducted. Data were obtained by chart review and a multipoint data sheet was used to abstract the data from the patient charts. RESULTS: Eighteen cases of prostate cancer were identified from six institutions. Most (84%) of the cancers were clinically localized at the time of diagnosis. Nine (50%) of 18 patients underwent radical prostatectomy, which was the predominant mode of treatment. Overall survival at a mean follow-up of 32 months was 66%, with a cancer specific mortality of 16%. Mortality was 13% for the 15 patients with localized disease and 33% for the 3 patients with metastatic disease at the time of diagnosis. CONCLUSIONS: Most of the patients with prostate cancer being detected after solid organ transplantation were diagnosed with localized disease. Aggressive therapeutic intervention as in the general (nontransplant) population yields good results and should be pursued. Diligent surveillance for prostate cancer in this population using periodic digital rectal examination, serum prostate-specific antigen, and prostate needle biopsy as needed will ensure earlier cancer detection and allow for definitive therapeutic intervention.

Aged↗
PubMed1996

The role of mycophenolate mofetil in clinical renal transplantation.

Mycophenolate mofetil (MM) is the ester derivative of mycophenolic acid (MPA), which exerts immunosuppressive activity by inhibiting de novo purine biosynthesis. Following animal models and pilot studies in human renal allograft recipients that confirmed MM's ability to prevent and half rejection episodes, 3 large multicenter studies of 500 patients each were conducted in North America, Europe, and Australia to compare MM with azathioprine or placebo, all drugs being used in conjunction with prednisone and cyclosporine. The results demonstrated a statistically significant reduction in episodes of allograft rejection in the MM groups with a concomitant reduction in the use of antirejection therapy, especially antilymphocyte antibody therapy. Adverse-event profiles were similar for all groups, although there were slightly more gastrointestinal and tissue-invasive cytomegalovirus (CMV) episodes in the MM groups. It is concluded that MM, which recently received Food and Drug Administration (FDA) approval in the United States, should be an important addition to the transplant physician's immunosuppressive armamentarium.

Clinical Trials as Topic↗
PubMed1996

Long-term follow-up of kidneys transplanted from elderly cadaveric donors.

This report examines the long-term results obtained in 50 patients transplanted between 1977 and 1990 with kidneys from cadaveric donors aged 55-70 (median 59) years. The recipients comprised 27 men and 23 women aged 8-68 (median 42) years. In all, 20 patients (40%) had end-stage renal disease on the basis of glomerulonephritis, whereas 8 (16%) were diabetic. Immunosuppression was induced with antilymphocyte globulin and maintained with azathioprine and prednisone in all patients in addition to cyclosporine in the 35 patients transplanted since 1985. Immediate graft function occurred in 18 patients (36%), and 36 patients (72%) were off dialysis at 1 year posttransplant. Altogether, 25 patients (50%) had functioning grafts at 5 years posttransplant, and at up to 13 years of follow-up (mean 5.8 years), 22 patients (44%) are off dialysis and their serum creatinine levels range from 0.8 to 3.8 mg/dl (mean 2.0 mg/dl). In all, 12 patients (24%) expired from 2 months to 15.5 years posttransplant (mean 4.3 years), and 5 of these patients died with functioning grafts. These 5 deceased recipients and the 22 who remain alive with functioning grafts had a mean antigen match of 2.27 with their donors. The other 23 patients whose grafts failed had a mean antigen match of 2.13 (P = 0.77). The 15 recipients who were transplanted prior to the cyclosporine era had lower 1- and 5-year allograft survival rates of 67% and 47%, respectively, as compared with their counterparts, who took cyclosporine-based immunosuppression (74% and 51%, P = 0.58 and 0.76, respectively). Likewise, the 32 recipients with delayed graft function had lower 1- and 5-year allograft survival rates of 66% and 47%, respectively, as compared with the group with immediate graft function (83% and 56%, P = 0.18 and 0.56, respectively). We conclude that acceptable long-term patient and graft survival may be achieved by transplanting these organs and that the degree of HLA matching does not affect their outcome significantly. Patients with immediate allograft function also tended to do better over the long term. Although cyclosporine-based immunosuppression was advantageous within 1 year of transplant, its beneficial effect was less marked 5 years out.

Adolescent↗
PubMed1996

Lovastatin has direct renal hemodynamic effects in a rodent model.

PURPOSE: Lovastatin, an HMG-CoA reductase inhibitor, has been shown to preserve renal function in models of chronic renal failure. We determined the effect of lovastatin on renal function and hemodynamics in normal nonpathologic kidneys in a rodent model. MATERIALS AND METHODS: Renal function was measured in anesthetized (Inactin) control rats (n = 13) and lovastatin-treated rats (15 mg./kg./day, 3 weeks, orally, n = 17). Renal blood flow was measured with an ultrasonic flowprobe, and glomerular filtration rate was measured by inulin clearance. The effect of lovastatin on pre- and postglomerular vessel diameters was also observed in a hydronephrotic kidney preparation by videomicroscopy. RESULTS: Lovastatin significantly increased (p < 0.05) renal blood flow and glomerular filtration rate by 17% (3.4 +/- 0.2 ml./min./gram kidney weight (gKW) versus 2.9 +/- 0.2 ml./min./gKW) and 49% (0.67 +/- 0.04 ml./min./gKW versus 0.45 +/- 0.06 ml./min./gKW). The increase in renal blood flow was mediated by preglomerular vasodilation (expressed as percent increase from baseline diameter, n = 20), 25% in the interlobular artery and 20% in the afferent arteriole (p < 0.05). CONCLUSIONS: In addition to its known lipid-lowering properties, lovastatin has a direct renal hemodynamic effect, increasing renal blood flow and glomerular filtration rate in normal nonpathologic kidneys. Lovastatin's selective preglomerular vasodilation may account for the observed increase in renal blood flow and glomerular filtration rate. Accordingly, this additional hemodynamic effect may be useful in preserving renal function in models of chronic renal failure.

Animals↗
PubMed1995

Transperitoneal marsupialization of lymphoceles: a comparison of laparoscopic and open techniques.

This 2-center study compares the relative merits of laparoscopic and open surgical internal marsupialization of pelvic lymphoceles. Laparoscopic lymphocelectomy was performed in 12 patients (group 1). The results were compared with open lymphocelectomy performed in 13 contemporary patients (group 2) as well as 13 historical patients (group 3). Operative time was longer in group 1 compared to groups 2 and 3 (194.6 versus 176.9 versus 133.8 minutes, respectively). However, group 1 had a decreased blood loss (23.1 versus 74.6 versus 61.7 ml.), earlier resumption of oral food intake (0.9 versus 2.5 versus 2.1 days), shorter hospital stay (2 versus 6.1 versus 6.3 days) and abbreviated convalescence (2.2 versus 6.9 versus 4.5 weeks) compared to groups 2 and 3. Complications included cystotomy requiring open repair in 1 patient in group 1, prolonged ileus in 1 in group 2, transection of the ureter of a transplant kidney in 1 in group 3 and pneumonitis in 1 in group 3. Lymphocele recurred in no patient in group 1, 4 in group 2 and 3 in group 3. Mean followup in groups 1 to 3 was 12.8, 25 and 54.5 months, respectively. We conclude that laparoscopic lymphocelectomy is effective, results in minimal patient morbidity and allows for a more rapid recovery compared to open surgical lymphocelectomy.

Adult↗