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Goal Directed Fluid Administration for Kidney Transplantation

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
goal directed fluid therapy
Control Group
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Kidney transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    goal directed fluid therapy

    Control Group

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney
    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
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    July 7, 2014
    Last Updated
    April 6, 2018
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02192086
    Brief Title
    Goal Directed Fluid Administration for Kidney Transplantation
    Official Title
    The Effect of Non-Invasive Goal Directed Fluid Administration on Graft Function in Kidney Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease
    Keywords
    Kidney transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    goal directed fluid therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    goal directed fluid therapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control Group
    Intervention Description
    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 Measure Information:
    Title
    Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney
    Description
    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.
    Time Frame
    1 year
    Title
    Pleth Variability
    Description
    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).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William Hand, MD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Scott T Reeves, MD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Goal Directed Fluid Administration for Kidney Transplantation

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