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

Primary Purpose

ARDS, Fluid Management, Cardiometry

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Electrical cardiometry
Fluid and Catheter Treatment Trial "FACTT Lite"
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Electrical cardiometry (EC)

Fluid and Catheter Treatment Trial "FACTT Lite"

Arm Description

Outcomes

Primary Outcome Measures

Percentage of mortality at 28th day
Percentage of mortality at 28th day in each group

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2019
Last Updated
April 22, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04219150
Brief Title
Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients
Official Title
Comparative Study Between Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Fluid Management, Cardiometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical cardiometry (EC)
Arm Type
Experimental
Arm Title
Fluid and Catheter Treatment Trial "FACTT Lite"
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electrical cardiometry
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluid and Catheter Treatment Trial "FACTT Lite"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of mortality at 28th day
Description
Percentage of mortality at 28th day in each group
Time Frame
28 day
Secondary Outcome Measure Information:
Title
Oxygenation index
Description
Higher scores mean a better outcome.
Time Frame
28 day
Title
Lung injury score
Description
Higher scores mean a worse outcome.
Time Frame
28 day
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation (days) in each group
Time Frame
28 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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