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

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

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).

Study Overview

• Status: Completed
• Conditions: ARDS; Cardiometry; Fluid Management
• Intervention / Treatment: Device: Electrical cardiometry; Drug: Fluid and Catheter Treatment Trial "FACTT Lite"

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31511
      • Tanta University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electrical cardiometry (EC)	Device: Electrical cardiometry; Four sensors of EC will be applied : first approximately 5 cm above the base of the neck, second on the base of neck, third on the lower thorax at the level of the xiphoid and the fourth one on the lower thorax approximately 5 cm below the 3rd electrode at the level of anterior axillary line. The EC monitor (Electrical Cardiometry monitor, ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, serial number 1725303) will be connected to the sensor cable and the patient data will be fed. Corrected flow time (FTC) and stroke volume (SV) will be measured continuously in less than 30 seconds after placing the sensors and inputting the height and weight.
EXPERIMENTAL: Fluid and Catheter Treatment Trial "FACTT Lite"	Drug: Fluid and Catheter Treatment Trial "FACTT Lite"; The FACTT Lite provided three possible instructions determined by the CVP and urine output: furosemide administration, fluid bolus, or no intervention. FACTT Lite contained instructions to withhold furosemide until the patient achieved a mean arterial pressure greater than 60 mmHg off of vasopressors for at least 12 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mortality at 28th day	Percentage of mortality at 28th day in each group	28 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2020
• Primary Completion (ACTUAL): February 10, 2021
• Study Completion (ACTUAL): February 20, 2021

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (ACTUAL): January 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 32721/11/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No