GDT Vs ST for Pancreas Transplant Surgery

This study has been completed.
Sponsor:
Collaborator:
Central Manchester University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Hussein Khambalia, University of Manchester
ClinicalTrials.gov Identifier:
NCT01619904
First received: June 12, 2012
Last updated: December 1, 2015
Last verified: December 2015

June 12, 2012
December 1, 2015
November 2011
March 2015   (final data collection date for primary outcome measure)
Length of Hospital Stay [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01619904 on ClinicalTrials.gov Archive Site
Inflammatory marker levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
GDT Vs ST for Pancreas Transplant Surgery
Effects of Goal-Directed Therapy on Inflammatory Mediators and Postoperative Outcome in Pancreas Transplant: a Prospective Randomised Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreas Transplantation
  • Procedure: Goal-Directed Therapy
    Peri-operative optimisation of fluid status, based on Oxygen Delivery
  • Procedure: Standard Therapy
    Following standard protocol during peri-operative period
  • Experimental: Goal-Directed Therapy
    Intervention: Procedure: Goal-Directed Therapy
  • Active Comparator: Standard Therapy
    Intervention: Procedure: Standard Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01619904
HAK 14
No
Not Provided
Not Provided
Hussein Khambalia, University of Manchester
University of Manchester
Central Manchester University Hospitals NHS Foundation Trust
Principal Investigator: Hussein A Khambalia, BMBS CMFT, University of Manchester
University of Manchester
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP