GDT Vs ST for Pancreas Transplant Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Manchester
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: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Pancreas Transplantation
Procedure: Goal-Directed Therapy
Procedure: Standard Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory marker levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619904

Contacts
Contact: Hussein A Khambalia, BMBS 01612761234 hussein.khambalia@cmft.nhs.uk

Locations
United Kingdom
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Hussein A Khambalia, BMBS    01612761234      
Sponsors and Collaborators
University of Manchester
Central Manchester University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Hussein A Khambalia, BMBS CMFT, University of Manchester
  More Information

No publications provided

Responsible Party: Hussein Khambalia, Senior Clinical Research Fellow, University of Manchester
ClinicalTrials.gov Identifier: NCT01619904     History of Changes
Other Study ID Numbers: HAK 14
Study First Received: June 12, 2012
Last Updated: February 7, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Manchester:
Pancreas Transplantation
Goal-directed therapy
Outcomes
Immunometric

Additional relevant MeSH terms:
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014