GDT Vs ST for Pancreas Transplant Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01619904
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : December 3, 2015
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Hussein Khambalia, University of Manchester

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Inflammatory marker levels [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All adult pancreas transplant recipients between November 2011- November 2013

Exclusion Criteria:

  • Those unable to consent
  • Paediatric recipients
  • Patients unable to meet follow-up protocol
  • Patients with a contra-indication to central venous catheterisation
  • Patients with advanced directives, restricting the implementation of the study protocol

Information from the National Library of Medicine

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 identifier (NCT number): NCT01619904

United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
University of Manchester
Manchester University NHS Foundation Trust
Principal Investigator: Hussein A Khambalia, BMBS CMFT, University of Manchester

Responsible Party: Hussein Khambalia, Senior Clinical Research Fellow, University of Manchester Identifier: NCT01619904     History of Changes
Other Study ID Numbers: HAK 14
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Hussein Khambalia, University of Manchester:
Pancreas Transplantation
Goal-directed therapy

Additional relevant MeSH terms:
Gastrointestinal Agents