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Clinical Trials/CTRI/2024/06/069384
CTRI/2024/06/069384
Recruiting
Not Applicable

Evaluation of fluid overload in Septic patients admitted to intensive care unit with Combined Venous Excess Lung Ultrasound (VExLUS) Score

All India Institute of Medical Sciences Patna1 site in 1 country93 target enrollmentStarted: July 5, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
All India Institute of Medical Sciences Patna
Enrollment
93
Locations
1
Primary Endpoint
Incidence of global fluid overload by measuring VExLUS score

Overview

Brief Summary

Hemodynamic management in critically ill septic patients has been traditionally focused on maintaining adequate cardiac output and arterial blood pressure by relying on fluid administration along with vasopressor and inotropic support. However, administration of fluid may lead to venous congestion compromising the organ perfusion which can be overlooked as a hemodynamic parameter on clinical assessment, and could be of utmost importance in management. Point of care ultrasound (POCUS) at  bedside allows the clinician to assess the status of intravascular volume and rule out portal, intrarenal  and pulmonary fluid overload. The correlation of  modified lung ultrasound score and extravascular fluid is a well-known parameter for the assessment of the global fluid status of the patient. Adding a lung ultrasound score to VExUS grading is a novel concept. Lung ultrasound evaluates 6 different lung areas,looking at B lines and graded 0,1,2,3. VExUS protocol evaluates the amount of venous congestion in the abdominal organs, specifically by scanning the portal, hepatic, and intra-renal veins. Doppler interrogation of these vessels yields a specific pattern corresponding to a level of venous congestion: normal, mild, or severe. By combining   modified lung ultrasound score and  VExUS grading, might lead to improvement in the sensitivity of early  fluid overload detection.This is a kind of study to evaluate the VExLUS grades in earlier identification of fluid overload in septic patients.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosis of sepsis (consistent with surviving sepsis campaign guidelines 2021 and clinical indication to be admitted in ICU).

Exclusion Criteria

  • Patients in hemodialysis program Patients with previously known conditions that interfere with portal Doppler assessments, namely liver cirrhosis, or severe tricuspid regurgitation with structural heart disease.
  • If any of these conditions are identified during the present episode, the patient would also be excluded.
  • Age less than 18 years Patients subjected to withdrawal of care Hemodynamic instability due to active hemorrhage Acute coronary syndrome Indication for immediate surgery Received CPR within 24 hours of enrollment Pregnancy.

Outcomes

Primary Outcomes

Incidence of global fluid overload by measuring VExLUS score

Time Frame: 0-12hrs | 24-36hrs | 48-72hrs | Discharge time

Secondary Outcomes

  • To asses correlation between VexLUS score and cumulative fluid balance(0-12hrs)
  • To asses correlation between VexLUS score and acute kidney injury(0-12hrs)
  • To asses correlation between VexLUS score and ICU length stay(0-12hrs)
  • To asses correlation between VexLUS score and congestive respiratory failure(not attributed to other causes)(0-12hrs)
  • Proportion of the need for diuretic use or Renal Replacement therapy to correct fluid overload(0-12hrs)
  • To predict 28 day mortality on VexLUS score(0-12hrs)

Investigators

Sponsor
All India Institute of Medical Sciences Patna
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr D Prithvi

AIIMS Patna

Study Sites (1)

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