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Clinical Trials/NCT02192086
NCT02192086
Completed
Early Phase 1

The Effect of Non-Invasive Goal Directed Fluid Administration on Graft Function in Kidney Transplantation

Medical University of South Carolina0 sites21 target enrollmentAugust 2012

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Medical University of South Carolina
Enrollment
21
Primary Endpoint
Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
July 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney

Time Frame: 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

Time Frame: 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).

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