ARDS, Fluid Management, Cardiometry
Conditions
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).
Interventions
DEVICEElectrical 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.
DRUGFluid 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of mortality at 28th day | 28 day | Percentage of mortality at 28th day in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung injury score | 28 day | Higher scores mean a worse outcome. |
| Oxygenation index | 28 day | Higher scores mean a better outcome. |
| Duration of mechanical ventilation | 28 day | Duration of mechanical ventilation (days) in each group |
Countries
Egypt
Outcome results
None listed