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Completed

NCT Number: NCT04219150

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).

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Key information

Conditions

ARDS Cardiometry Fluid Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical cardiometry

Device

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.

Fluid and Catheter Treatment Trial "FACTT Lite"

Drug

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 outcomes

  1. Percentage of mortality at 28th day

    Time frame: 28 day

    Percentage of mortality at 28th day in each group

Secondary outcomes

  1. Oxygenation index

    Time frame: 28 day

    Higher scores mean a better outcome.

  2. Lung injury score

    Time frame: 28 day

    Higher scores mean a worse outcome.

  3. Duration of mechanical ventilation

    Time frame: 28 day

    Duration of mechanical ventilation (days) in each group

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2020
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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