GDT Vs ST for Pancreas Transplant Surgery
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|ClinicalTrials.gov Identifier: NCT01619904|
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : December 3, 2015
A Pancreas Transplant is the accepted treatment in patients with Insulin Dependent Diabetes Mellitus (IDDM) and end-organ failure. Simultaneous Pancreas and Kidney (SPK) Transplant is done in over 90% of cases. At present there is a 5- 8% 30-day mortality with over 80% graft survival at 1 year. At Manchester Royal Infirmary (MRI) approximately 40 cases are done per year.
Goal-Directed Therapy (GDT) involves fluid resuscitation intra-operatively and early in the post-operative period, guided by cardiac output monitoring. The mechanism of therapeutic benefit is thought to be related to improved tissue oxygenation and oxygen delivery. There are a number of studies showing significantly improved biochemical markers of inflammation in animal models and in studies on septic patients (patients with an overwhelming infection) following GDT. Studies have also shown that GDT improves clinical outcome in post-operative patients and in serum inflammatory mediators. These studies have looked at "major abdominal surgery" but none have investigated transplant patients. Given the nature of surgery we feel that our patients would benefit with reduced Intensive Care Unit stay, reduced length of hospital stays and reduced rates of post-operative complications.
The study will be conducted on all adult patients undergoing pancreas transplant at MRI. It will last for 2 years and we hope to recruit 60 patients
Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being current practice. Each intervention will last for six hours post-operatively before continuing with normal care thereafter. Omental fat biopsies will be taken from patients intra-operatively and blood samples will be taken from patients at regular intervals for 72 hours intra- and post- operatively. Patients will be followed up daily while an in-patient and at three-monthly intervals in out-patients for 1 year.
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Transplantation||Procedure: Goal-Directed Therapy Procedure: Standard Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Goal-Directed Therapy on Inflammatory Mediators and Postoperative Outcome in Pancreas Transplant: a Prospective Randomised Clinical Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
|Experimental: Goal-Directed Therapy||
Procedure: Goal-Directed Therapy
Peri-operative optimisation of fluid status, based on Oxygen Delivery
|Active Comparator: Standard Therapy||
Procedure: Standard Therapy
Following standard protocol during peri-operative period
- Length of Hospital Stay [ Time Frame: 2 years ]
- Inflammatory marker levels [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619904
|Manchester Royal Infirmary|
|Manchester, United Kingdom, M13 9WL|
|Principal Investigator:||Hussein A Khambalia, BMBS||CMFT, University of Manchester|