Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients

University of Indonesia (UI)

Status: Completed

Conditions: Septic Shock

Treatments: Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg; Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT04156451

IndonesiaUAnes040

Details and patient eligibility

About

A scientific research to prove the safety and effectiveness of TVS 0 - 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) > 25 mm / mm2, AKI stage (based on KDIGO criteria), CI > 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use <120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation

Full description

The study aims to evaluate the effectiveness of deresuscitation with target CVP 0 - 4 mmHg on septic shock patients in the ICU on capillary perfusion density, AKI stage (based on KDIGO criteria), the incidence of intubation, duration of use of mechanical ventilation, and length of stay in the ICU which can reduce the number of morbidity and mortality.

The study evaluates the difference in capillary perfusion density, AKI stage (based on KDIGO criteria), and the Cardiac index value between groups septic shock patients with CVP 0-4 mmHg on the 7th day after deresuscitation compared with the control group (CVP 8-10 mmHg on the first 7th day after being given deresuscitation).

The study evaluates the difference in the number of intubation incidents, duration of use ventilators, and care in the ICU between groups of patients with septic shock CVP 0 - 4 on day 28 after being given a degree of comparison with a control group (CVP 8-10 mmHg on day 28th after being deresuscitation).

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Septic shock patients who meet the diagnosis criteria for quick SOFA and KDIGO 1 stage AKI (creatinine value 1.5 times OR creatinine value> 0.3 initial OR urine production <0.5 ml/kg/hour for 6-12 hours
• Patients, both men and women, in the age range of 18 - 60 years
• Patients who experience post clean operative sepsis
• Patients who agree to attend the study by signing informed consent

Exclusion criteria

• Patients with primary heart problems, right or heart failure suffer from congenital heart disease
• Have severe chronic obstructive pulmonary disease, patients with severe pleural effusion
• Patients who, based on ultrasound examination, found stones or tumors in the kidney during the study period
• CKD patients are based on history taking and physical examination
• DNR (do not resuscitate) patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Central Venous Pressure 8 - 10 mmHg

Active Comparator group

Description:

Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached

Treatment:

Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg

Central Venous Pressure 0 - 4 mmHg

Experimental group

Description:

Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached

Treatment:

Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg