None listed
Conditions
Brief summary
Accurate fluid management in the peritransplant period is crucial. In many cases the donor renal allograft will have established acute tubular necrosis due to prolonged cold ischaemic time and will therefore have delayed graft function. A common complication of transplant surgery is over aggressive fluid replacement in a patient who is essentially anuric which may precipitate pulmonary oedema requiring urgent dialysis. On the other hand, inadequate volume replacement in a renal allograft recipient who has immediate graft function can result in hypovolaemia and potentially delayed graft function. The ODM has been used in case series of renal transplantation demonstrating efficacy and safety. This prospective, randomized trial looks at goal directed fluid therapy using the oesophageal doppler monitor versus standard of care fluid therapy in renal transplant patients to determine if there is a reduced length of stay and reduced incidence of delayed graft function.
Interventions
Patients presenting for renal transplant will be randomized to intra-operative standard fluid therapy(SFT) or intra-operative goal directed fluid therapy using the oesophageal doppler monitor(ODM). All patients will be asked for their duration of preoperative fasting, and time since last dialysis. All patients will be pre-warmed with a forced air warming blanket and intravenous access will be obtained. An arterial line will be inserted only if deemed indicated by the treating anaesthetist.
Onc
Patients presenting for renal transplant will be randomized to intra-operative standard fluid therapy(SFT) or intra-operative goal directed fluid therapy using the oesophageal doppler monitor(ODM). All patients will be asked for their duration of preoperative fasting, and time since last dialysis. All patients will be pre-warmed with a forced air warming blanket and intravenous access will be obtained. An arterial line will be inserted only if deemed indicated by the treating anaesthetist. Once monitored with standard monitoring, a general anaesthetic induction will be commenced with propofol, fentanyl and atracurium. Maintenance of anaesthesia will be with desflurane, fentanyl and an atracurium infusion. Routine immunosuppressive and antibiotic therapy will be administered as per institutional specific therapy. In ODM Group patients a oesophageal doppler monitor will be inserted after intubation of the trachea and in the ODM group goal directed fluid therapy commenced as guided by the ODM. FTc<350 Normal Saline 7 ml/kg initially then subsequently 3 ml/kg will be administered as a fluid challenge, to return FTc to > 350, as per GUIDELINES FOR IMPLEMENTATION OF ENHANCED RECOVERY PROTOCOLS (1) December 2009. FTc >400 and MAP <70 mmHg metaraminol (heart rate >60 bpm) or ephedrine (heart rate <60 bpm) shall be administered. For the SFT group fluid, vasoconstrictor and ephedrine administration shall be at the discretion of the treating anaesthestist. Total doses of vasoconstrictor and inotrope shall be documented for the intraoperative period for both groups. (1) Shakeeb Khan et al GUIDELINES FOR IMPLEMENTATION OF ENHANCED RECOVERY PROTOCOLS December 2009
Sponsors
Ruari M Orme
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients for renal transplant
Exclusion criteria
refusal severe pharyngo-oesophageal disease known severe aortic-arch disease
Outcome results
None listed