NCT01619904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

June 12, 2012

Last Update Submit

December 1, 2015

Conditions

Pancreas Transplantation

Keywords

Pancreas TransplantationGoal-directed therapyOutcomesImmunometric

Outcome Measures

Primary Outcomes (1)

  • Length of Hospital Stay

    2 years

Secondary Outcomes (1)

  • Inflammatory marker levels

    2 years

Study Arms (2)

Goal-Directed Therapy

EXPERIMENTAL
Procedure: Goal-Directed Therapy

Standard Therapy

ACTIVE COMPARATOR
Procedure: Standard Therapy

Interventions

Goal-Directed TherapyPROCEDURE

Peri-operative optimisation of fluid status, based on Oxygen Delivery

Goal-Directed Therapy
Standard TherapyPROCEDURE

Following standard protocol during peri-operative period

Standard Therapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester Royal Infirmary

Manchester, Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

Early Goal-Directed TherapyStandard of Care

Intervention Hierarchy (Ancestors)

Critical CarePatient CareTherapeuticsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Hussein A Khambalia, BMBS

    CMFT, University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Clinical Research Fellow

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

GB(1)