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Goal Directed Fluid Administration for Kidney Transplantation

6 april 2018 uppdaterad av: Medical University of South Carolina

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

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

21

Fas

  • Tidig fas 1

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

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.

Aktiv komparator: 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).

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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney
Tidsram: 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.
1 year
Pleth Variability
Tidsram: 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).
1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: William Hand, MD, Medical University of South Carolina

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2012

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

7 juli 2014

Först inskickad som uppfyllde QC-kriterierna

14 juli 2014

Första postat (Uppskatta)

16 juli 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 april 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 april 2018

Senast verifierad

1 april 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Fluid Kidney Transplants

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på goal directed fluid therapy

3
Prenumerera