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Clinical Trials/CTRI/2025/01/079664
CTRI/2025/01/079664Not yet recruitingNot Applicable

ARDS henotype and its association with Right ventricle dysfunction trajectory

All India Institute Of Medical Science1 site in 1 country114 target enrollmentStarted: February 10, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
114
Locations
1
Primary Endpoint
To know the association between ARDS phenotypes (hypo inflammatory vs hyper inflammatory and pulmonary vs extrapulmonary , focal vs diffuse)

Study Overview

Brief Summary

INCLUSION CRITERIA:

1.     Adult patients with ARDS as per Berlin definition10 and expanded definition.11

EXCLUSION CRITERIA

1.     Patients’ refusal

2.     Patient who had cardiac arrest in the recent admission

All patients in ED and ICU who meet the inclusion and exclusion criteria will be screened for enrolment within 24hr of diagnosis of ARDS. 2.5-MHz phased-array probe will be used for echocardiography. There will be no blinding of the clinical status to the investigator at the time of performance of Echocardiography.

The echocardiography will be performed by an experienced investigator who has conducted over 50 point-of-care echocardiograms, and it will be executed by a single observer.

The assessments will take place at the time of the patient’s arrival in the ICU, as well as on Day 1, Day 3, Day 7, and at the time of liberation from the ventilator. The parameters evaluated during the echocardiography will include Left Ventricular End-Diastolic Area (LVEDA), Left Ventricular Ejection Fraction (LVEF), Tricuspid Annular Plane Systolic Excursion (TAPSE), TAPSE/Pulmonary Arterial Systolic Pressure (PASP), TAPSE/Tricuspid Regurgitant Velocity (TRV), Central Venous Pressure (CVP), Inferior Vena Cava (IVC) Diameter, IVC Distensibility, and Pulmonary Artery Acceleration Time.

For each parameter, three measurements will be taken, and the average will be recorded. Additionally, the following ventilator parameters will be noted at the time of echocardiography: compliance, driving pressure, tidal volume, PEEP (Positive End-Expiratory Pressure), and respiratory rate. Basic laboratory parameters, including the P/F ratio (PaO2/FiO2), lactate levels, base excess, C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-18 (IL-18), and the neutrophil-to-lymphocyte ratio (NLR), will also be assessed. Finally, the APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment) scores will be calculated to evaluate the patients’ conditions comprehensively.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult patients with ARDS as per Berlin definition10 and expanded definition.11.

Exclusion Criteria

  • Patients’ refusal
  • Patient who had cardiac arrest in the recent admission.

Outcomes

Primary Outcomes

To know the association between ARDS phenotypes (hypo inflammatory vs hyper inflammatory and pulmonary vs extrapulmonary , focal vs diffuse)

Time Frame: Day 1,3,7 / Ventilation liberation

pattern of RV dysfunction RV dilatation isolated, RV dilatation with RV-PA uncoupled, RV dilatation with RV function impaired ) with or without shock

Time Frame: Day 1,3,7 / Ventilation liberation

Secondary Outcomes

  • Association between ARDS phenotypes & RV dysfunction trajectory(Association between RV dysfunction pattern & clinical outcome)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Vasundhara Rakhi

ALL INDIA INSTITUTE OF MEDICAL SCIENCE NEW DELHI

Study Sites (1)

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