GDT Vs ST for Pancreas Transplant Surgery

Pancreas Transplantation Clinical Trial

Official title:

Effects of Goal-Directed Therapy on Inflammatory Mediators and Postoperative Outcome in Pancreas Transplant: a Prospective Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619904
• Other study ID #: HAK 14
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: December 1, 2015
• Start date: November 2011
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreas Transplantation

Intervention

Procedure:
• Goal-Directed Therapy
Peri-operative optimisation of fluid status, based on Oxygen Delivery
• Standard Therapy
Following standard protocol during peri-operative period

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Central Manchester University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay		2 years	No
Secondary	Inflammatory marker levels		2 years	No