Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-11-30
2015-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Goal-Directed Therapy
Goal-Directed Therapy
Peri-operative optimisation of fluid status, based on Oxygen Delivery
Standard Therapy
Standard Therapy
Following standard protocol during peri-operative period
Interventions
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Goal-Directed Therapy
Peri-operative optimisation of fluid status, based on Oxygen Delivery
Standard Therapy
Following standard protocol during peri-operative period
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
University of Manchester
OTHER
Responsible Party
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Hussein Khambalia
Senior Clinical Research Fellow
Principal Investigators
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Hussein A Khambalia, BMBS
Role: PRINCIPAL_INVESTIGATOR
CMFT, University of Manchester
Locations
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Manchester Royal Infirmary
Manchester, Manchester, United Kingdom
Countries
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Other Identifiers
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HAK 14
Identifier Type: -
Identifier Source: org_study_id