Goal Directed Fluid Administration for Kidney Transplantation

Early Phase 1

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT02192086
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The goal of the proposed study is to evaluate the efficacy of a goal-directed fluid administration algorithm on early graft function in patients undergoing kidney transplantation. Fluid administration has increasingly been scrutinized within anesthesia related literature as an area for improvement, and the imbalance present between estimated blood loss and total fluid administered for kidney transplants must be amongst the highest case categories. Considering the patients are anuric for the majority of the procedure, unguided administration of multiple liters of crystalloid appears antiquated.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• end stage renal disease requiring dialysis
• age >18y
• normal cognitive function.

Exclusion Criteria

• severe left ventricular dysfunction (EF<50%)
• known cardiomyopathy
• symptomatic CAD known valvular disease
• severe anemia (Hgb<7.0)
• patients with prior transplants o
• patients who suffered surgical complications as communicated by the surgical team.

We chose these exclusion criteria to prevent enrolling patients who would not tolerate aggressive hydration possible in the treatment group. The exclusion criteria may be excessively restrictive, however, given the current practice that frequently results in rapid large volume loading without a monitor of intravascular volume status.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney	1 year	To determine the effect of plethysmography directed fluid administration on the incidence of delayed graft function in kidney transplantation.The treatment group will recieve fluid in a well described short period around the time of anastomosis based on a fingertip adhesive monitor. By preventing hypovolemia at the time of reperfusion, we expect the transplanted kidney to demonstrate improved function in the near term.
Pleth Variability	1 year	Pleth Variability Index (PVI) is a validated non-invasive monitoring method used to assess intravascular volume status, and may prove superior to dosing fluids based on existing parameters (heart rate, blood pressure, anecdotal protocols).