Clinical trial NCT01619904: GDT Vs ST for Pancreas Transplant Surgery
Official title: Effects of Goal-Directed Therapy on Inflammatory Mediators and Postoperative Outcome in Pancreas Transplant: a Prospective Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Transplantation
Keywords: Pancreas Transplantation
Goal-directed therapy
Outcomes
Immunometric
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2012-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: 2 years
Secondary outcomes:
measure: Inflammatory marker levels
timeFrame: 2 years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: CMFT, University of Manchester
name: Hussein A Khambalia, BMBS
role: PRINCIPAL_INVESTIGATOR
References: