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

T

Tanta University

Status

Completed

Conditions

Fluid Management
ARDS
Cardiometry

Treatments

Drug: Fluid and Catheter Treatment Trial "FACTT Lite"
Device: Electrical cardiometry

Study type

Interventional

Funder types

Other

Identifiers

NCT04219150
32721/11/18

Details and patient eligibility

About

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).

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Electrical cardiometry (EC)
Experimental group
Treatment:
Device: Electrical cardiometry
Fluid and Catheter Treatment Trial "FACTT Lite"
Experimental group
Treatment:
Drug: Fluid and Catheter Treatment Trial "FACTT Lite"

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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