Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients

Not Applicable

Completed

• Conditions: Fluid Management; ARDS; Cardiometry
• Interventions: Drug: Fluid and Catheter Treatment Trial "FACTT Lite"; Device: Electrical cardiometry

• Registration Number: NCT04219150
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study will be to compare the fluid management in acute respiratory distress syndrome ARDS guided by electrical cardiometry (EC) versus the guidance with simplified conservative fluid protocol, Fluid and Catheter Treatment Trial "FACTT Lite". Group (A) consists of 35 patients: Fluid management in this group will follow a simplified conservative fluid protocol, "FACTT Lite" The FACTT Lite provided three possible instructions determined by the CVP and urine output: furosemide administration, fluid bolus, or no intervention. Group (B) consists of 35 patients: Fluid will be allowed according to an FTc-based fluids algorithm protocol and the type of bolus fluids will be determined according to Transthoracic fluid content (TFC), vasopressors and inotropes will be given according to reading of EC reading of systemic vascular resistance (SVR) and index of contractility (I CON).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-22
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2020-01-10
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Acute onset within one week
• Mild to moderate ARDS (FiO2/PaO2) less than 300 mmHg and more than 100 mmHg with a minimum PEEP of 5 cmH2O
• Bilateral lung opacities consistent with pulmonary edema on chest radiogram or lung ultrasound, cardiac failure, and fluid overload should be excluded in the absence of a definite cause of ARDS
• ARDS due to pulmonary cause.

Exclusion Criteria

• Hemodynamic instability, patients on vasopressor,
• Barotrauma
• organ/s dysfunction at presentation.
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid and Catheter Treatment Trial "FACTT Lite"	Fluid and Catheter Treatment Trial "FACTT Lite"	-
Electrical cardiometry (EC)	Electrical cardiometry	-

Primary Outcome Measures

Name	Time	Method
Percentage of mortality at 28th day	28 day	Percentage of mortality at 28th day in each group

Secondary Outcome Measures

Name	Time	Method
Oxygenation index	28 day	Higher scores mean a better outcome.
Lung injury score	28 day	Higher scores mean a worse outcome.
Duration of mechanical ventilation	28 day	Duration of mechanical ventilation (days) in each group

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt