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Goal Directed Fluid Administration for Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT02192086
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: goal directed fluid therapy Other: Control Group Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Non-Invasive Goal Directed Fluid Administration on Graft Function in Kidney Transplantation
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: goal directed fluid therapy

The "treatment" group will initially be given a 1L bolus after induction over 20 minutes (first liter may be Lactated Ringers solution or Plasmalyte, subsequent fluid will be Plasmalyte) followed by maintenance infusion at a rate of 5mL/kg/hr until the graft kidney is removed from ice. After removing the organ from ice, the kidney recipient will be administered supplemental crystalloid until PVI is 10 or lower. Plasmalyte will be warmed in accordance to the departmental hypothermia protocol. A PVI of 12 or lower will be maintained until emergence of anesthesia, at which time the PVI monitor will be removed and all patients will be managed by existing standards (pain control, fluid replacement, hemodynamic goals, etc).

a.At the time the treatment group begins receiving goal directed fluid therapy the anesthesia team is to wean any vasopressors aggressively with the goal of terminating infusion as quickly as is safe.

Other: goal directed fluid therapy

The "treatment" group will initially be given a 1L bolus after induction over 20 minutes (first liter may be Lactated Ringers solution or Plasmalyte, subsequent fluid will be Plasmalyte) followed by maintenance infusion at a rate of 5mL/kg/hr until the graft kidney is removed from ice. After removing the organ from ice, the kidney recipient will be administered supplemental crystalloid until PVI is 10 or lower. Plasmalyte will be warmed in accordance to the departmental hypothermia protocol. A PVI of 12 or lower will be maintained until emergence of anesthesia, at which time the PVI monitor will be removed and all patients will be managed by existing standards (pain control, fluid replacement, hemodynamic goals, etc).

a.At the time the treatment group begins receiving goal directed fluid therapy the anesthesia team is to wean any vasopressors aggressively with the goal of terminating infusion as quickly as is safe.


Active Comparator: Control Group

Control patients will be given a constant infusion of crystalloid (first liter may be Lactated Ringers solution or Plasmalyte, subsequent fluid will be Plasmalyte) at a rate determined by the following: 70mL/kg for the duration of the surgery, 1L bolus after induction (over 20-30 minutes) followed by the remainder as a constant infusion determined by (70mL/kg * wt - 1000mL) / 160 minutes (using the local average of approximately 180 minutes of operative time).

a.A Masimo PVI monitor will be placed on the patient on an extremity not affected by an AV fistula and recorded for evaluation, but no fluid administration decisions will be made based on it (providers will not have access to its values).

Other: Control Group

Control patients will be given a constant infusion of crystalloid (first liter may be Lactated Ringers solution or Plasmalyte, subsequent fluid will be Plasmalyte) at a rate determined by the following: 70mL/kg for the duration of the surgery, 1L bolus after induction (over 20-30 minutes) followed by the remainder as a constant infusion determined by (70mL/kg * wt - 1000mL) / 160 minutes (using the local average of approximately 180 minutes of operative time).

a.A Masimo PVI monitor will be placed on the patient on an extremity not affected by an AV fistula and recorded for evaluation, but no fluid administration decisions will be made based on it (providers will not have access to its values).





Primary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192086


Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: William Hand, MD Medical University of South Carolina
Study Chair: Scott T Reeves, MD Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02192086     History of Changes
Other Study ID Numbers: Fluid Kidney Transplants
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Medical University of South Carolina:
Kidney transplantation

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Plasma-lyte 148
Pharmaceutical Solutions
Ophthalmic Solutions