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

Not Applicable

Completed

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

• Registration Number: NCT04156451
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2019-11-14
• Primary Completion: 2020-09-30
• Study Completion: 2020-11-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Central Venous Pressure 8 - 10 mmHg	Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg	Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached
Central Venous Pressure 0 - 4 mmHg	Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg	Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached

Primary Outcome Measures

Name	Time	Method
Capillary Perfusion Density	7 days	Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Secondary Outcome Measures

Name	Time	Method
Renal Resistive Index (RRI)	1st and 7th day	RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation
Cardiac Index	7 days	cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation
Neutrophil Gelatinase-Associated lipocalin (NGAL)	1st and 7th day	NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation
Acute Kidney Injury Stage	7 days	AKI staging using KDIGO criteria every 24 hours during deresuscitation
Length of ICU stay	28 days	length of ICU stay in days during and after deresuscitation

Trial Locations

Locations (1)

Rumah Sakit Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia