Effects of Goal-Directed Therapy on Inflammatory Mediators and Postoperative Outcome in Pancreas Transplant: A Prospective, Randomised Clinical Trial
A Pancreas Transplant is the treatment for patients with Insulin Dependent Diabetes Mellitus (IDDM) and organ failure. However, at present there is a high mortality with approximately 80% one-year graft survival.
Goal-Directed Therapy (GDT) involves achieving specific targets, based on the amount of oxygen delivered to the tissues. The therapy aims to increase the amount of oxygen delivered to tissues and thereby reduces levels of inflammation. Studies have shown that GDT improves outcomes. These studies have looked at “major abdominal surgery” but none have looked at transplant patients. Given the nature of the surgery we feel that our patients would benefit with reduced Intensive Care Unit stays, reduced length of hospital stays and reduced rates of post-operative complications.
This study will be conducted on all adult patients undergoing Pancreas Transplantation at the Manchester Royal Infirmary (MRI) between November 2011 and November 2013. Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being the current practice of looking after patients. Each intervention will last for six hours post- surgery before continuing with normal care thereafter. Blood samples will be taken from patients at regular intervals for 72 hours post-surgery and the levels of markers of inflammation in these blood samples will be measured. Patients will be followed-up daily while an inpatient and in outpatients for 1 year (at three-monthly intervals) post-transplant to assess the function of the grafts and for any post-operative complications.