A comparison of the effects of oral vs. intravenous hydration on subclinical acute kidney injury in living kidney donors: a protocol of a randomised controlled trial.
Mackinnon S, Aitken E, et al.BMC Nephrology 2017; 18(1): 30.
Aims
To determine the effects of donor preoperative intravenous fluids compared to oral hydration in living kidney donors.
Interventions
Participants will be randomised to receive either active prehydration with three litres of intravenous Hartmann’s solution between midnight and 8am with unlimited oral fluid as desired, versus unlimited oral fluids only until midnight.
Participants
Adult patients aged >18 years of age undergoing live donor hand-assisted laparoscopic nephrectomy.
Outcomes
The primary outcome measured will be the incidence of donor acute kidney injury on day 1 post-operatively. Secondary outcomes will include intraoperative haemodynamics, recipient subclinical acute kidney injury, perioperative complications and donor sleep quality.
Follow-up
1 year
CET Conclusions
This is a trial protocol of a single centre, single-blinded randomised controlled trial comparing the effect of intravenous hydration on subclinical acute kidney injury in living kidney donors. Living kidney donors will be randomised to 3 litres of intravenous Hartmann’s solution between midnight and 8am before morning donation with unlimited oral fluids versus unlimited oral fluids until midnight alone. The randomisation sequence will be computer-generated and allocation will be concealed by using sealed, opaque envelopes. The primary outcome is the incidence of plasma NGAL>153ng/ml on day 1 posttransplant as a biomarker for donor acute kidney injury. Secondary outcomes include donor and recipient biochemical and clinical outcomes. The power calculation showed that 43 donors per group are needed to detect a 30% difference in the incidence rate of acute kidney injury, allowing for 10% dropout/withdrawal. Outcome assessment and data entry will be done in a blinded fashion.
Quality notes
Quality assessment not appropriate
Trial registration
ISRCTN - 10199225