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Fluid Management in the Post Anesthesia Care Unit

NCT03799250 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-09-25

No results posted yet for this study

Summary

Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management.

While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce.

In this study the investigators aim to evaluate the efficacy of bolus-based fluid management guided by common clinical parameters in postoperative period in post-anesthesia care unit.

In this randomized clinical trial all patients will be randomized to one of the following groups:

The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.

The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.

Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.

Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.

Conditions

  • Ringer's Lactate

Interventions

DRUG

Ringer lactate

Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU

OTHER

standard care

standard care

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Nadav O Sheffy, MD · Rabin Medical Center

  • Leonid O Eidelman, MD · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799250 on ClinicalTrials.gov