Does post fliuid resuscitation in patients with sepsis,a protocolised fluid removal guided by ultrasound using VExUS protocol as compared to routine practice results in a better outcome?

Not Applicable

Conditions: Health Condition 1: B95-B97- Bacterial and viral infectious agents

Registration Number: CTRI/2023/05/052965

Lead Sponsor: Kovai Medical Centre Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

All patients admitted in the ICU with suspected sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following.

Systemic Inflammatory Response Syndrome (SIRS) criteria:

â?ª Temperature of > 38 C or < 36 C

â?ª Heart rate of > 90/min

â?ª Respiratory rate of > 20/min or PaCO2 < 32 mm Hg

â?ª White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands.

â?ª Known or suspected infection at the time of screening

â?ª Those patients in ICU within 24 hours of identification or suspicion of sepsis

Exclusion Criteria

â?ª Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis

â?ª Patients with severe chronic kidney disease (estimated glomerular filtration rate <15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula).

â?ª Age < 18 years

â?ª Hemodynamic instability due to active haemorrhage

â?ª Acute cerebral vascular event

â?ª Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)

â?ª Burn patients

â?ª Those who had cardiac arrest within 24 hours of enrolment and ROSC attained by CPR

â?ª Pregnancy patients

â?ª Patients with difficulty in obtaining ultrasound images of sufficient quality to calculate VExUS scoring

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim is to determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid de-resuscitation as compared to a standard protocol guided de resuscitation in septic patients is associated with a reduction in cumulative fluid balance from ICU admission until beginning of study days 3 and 5, and at ICU discharge.Timepoint: Cumulative fluid balance from ICU admission until beginning of study days 3 and 5, and at ICU discharge.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are to compare in both the groups: <br/ ><br>1.SOFA score at day 3 and day 5 of study in ICU <br/ ><br>2.Mortality at 28 and 180 days <br/ ><br>3.Duration of mechanical ventilation <br/ ><br>4.Length of hospital and ICU stay <br/ ><br>5.Adverse events if any in both groups <br/ ><br>6.Incidence of and improvement of acute kidney injury after correction of fluid balanceTimepoint: Patients will be looked for secondary objectives on day of study,day 3,day 5 and day of ICU discharge .No of hospital days in total and 6 month survival will be assessed