Fluid unLoading On Weaning (FLOW)

NCT04496583 | Unknown DMC

• 1 other identifier: 1200248
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if testing preload responsiveness, the normal physiologic state that means that changes in preload determine changes in cardiac output, allows an earlier and physiologically safer weaning from mechanical ventilation in critically ill patients with fluid overload, when compared to a strategy of fluid removal aimed at obtaining a predetermined negative fluid balance.

Conditions

Weaning Failure; Fluid Overload; Cardiac Failure Acute

Outcome Measures

Primary Outcomes (2)

• Proportion of patients on each study group presenting weaning-induced pulmonary edema or weaning failure from cardiovascular origin

  Development of signs of cardiac failure and acute pulmonary edema during the spontaneous breathing trial.

  72 hours

• Mean and standard deviation of T time between the starting of fluid depletion and consolidated weaning from mechanical ventilation on each study group.

  Time between the starting of fluid depletion and consolidated weaning from mechanical ventilation, measured in hours and days.

  7 days

Secondary Outcomes (3)

• Proportion of patients on each study group presenting weaning-induced global and regional hypoperfusion (lactate, capillary refill time, ScvO2, dCO2)

  72 hours

• Proportion of patients on each study group presenting depletion-induced renal dysfunction assessed by renal stress biomarkers variation.

  72 hours

• Proportion of patients on each study group presenting depletion-induced acid-base and electrolyte disturbances.

  72 hours

Study Arms (2)

Fluid Balance Depletive Strategy Group

ACTIVE COMPARATOR

Patients with fluid overload under a depletive strategy to attain a predetermined negative balance

Other: Fluid depletion strategy

Preload Responsiveness Depletive Strategy Group

EXPERIMENTAL

Patients with fluid overload under a depletive strategy to attain a state of preload responsiveness

Other: Fluid depletion strategy

Interventions

Fluid depletion strategy OTHER

The fluid depletion strategy will be individualized depending on the response to the standardized furosemide test (one-time dose of 1.0 or 1.5 mg/kg depending on prior furosemide-exposure) with a urinary output (UO) cutoff of 200 ml at 2 hours. The desired depletion endpoint will be targeted by using diuretics (40 mg q6h iv initially, adjusting dose by UO) or ultrafiltration (UF) if UO \<200 ml/2h

Fluid Balance Depletive Strategy Group; Preload Responsiveness Depletive Strategy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilation for \>24 hours and \<7 days
• Patients who on the daily evaluation to assess their potential for weaning present fluid overload and, in consequence, require fluid depletion before the spontaneous breathing trial
• Clinical condition resolving or hemodynamically stable condition with acceptable ventilatory status that allows an spontaneous breathing trial according to attending's criteria.

You may not qualify if:

• Pregnancy
• Do-not-resuscitate status
• Child B or C liver cirrhosis
• Circulatory instability
• Acute coronary syndrome
• Active bleeding
• Severe concomitant acute respiratory distress syndrome
• Malnutrition
• Muscle weakness severe enough to be considered by itself a risk for weaning failure
• Patient should be excluded based on the opinion of the clinician/investigator (documented reason)

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico UC CHRISTUS

Santiago, RM, 8330077, Chile

RECRUITING

Related Publications (1)

• Castro R, Kattan E, Hernandez G, Bakker J. Differential Cardiac Responses after Passive Leg Raising. J Clin Monit Comput. 2024 Oct;38(5):991-996. doi: 10.1007/s10877-024-01180-z. Epub 2024 Jun 6.

  PMID: 38844602 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Castro, MD, MPH

  School of Medicine, Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Kattan, MD, MSc

CONTACT

+56994793024; e.kattan@gmail.com

Ricardo Castro

CONTACT

+56973986588; rcastro@ucchristus.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective controlled study of parallel groups

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)