NCT04219150

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

December 22, 2019

Last Update Submit

April 22, 2021

Conditions

ARDSFluid ManagementCardiometry

Outcome Measures

Primary Outcomes (1)

  • Percentage of mortality at 28th day

    Percentage of mortality at 28th day in each group

    28 day

Secondary Outcomes (3)

  • Oxygenation index

    28 day

  • Lung injury score

    28 day

  • Duration of mechanical ventilation

    28 day

Study Arms (2)

Electrical cardiometry (EC)

EXPERIMENTAL
Device: Electrical cardiometry

Fluid and Catheter Treatment Trial "FACTT Lite"

EXPERIMENTAL
Drug: Fluid and Catheter Treatment Trial "FACTT Lite"

Interventions

Electrical cardiometryDEVICE

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.

Electrical cardiometry (EC)
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.

Fluid and Catheter Treatment Trial "FACTT Lite"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hemodynamic instability, patients on vasopressor,
  • Barotrauma
  • organ/s dysfunction at presentation.
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31511, Egypt

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Anesthesiology, Surgical ICU and Pain Medicine

Study Record Dates

First Submitted

December 22, 2019

First Posted

January 6, 2020

Study Start

January 10, 2020

Primary Completion

February 10, 2021

Study Completion

February 20, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)