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

Study Overview
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Brief Summary
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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).

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

Conditions
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ARDS, Fluid Management, Cardiometry

Intervention / Treatment
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* Device: Electrical cardiometry
* Drug: Fluid and Catheter Treatment Trial FACTT Lite


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical cardiometry (EC)<br> | Device: Electrical cardiometry<br>* 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.<br>|
| Experimental: Fluid and Catheter Treatment Trial FACTT Lite<br> | Drug: Fluid and Catheter Treatment Trial FACTT Lite<br>* 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.<br>|

What is the study measuring?
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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 |