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

Effectiveness of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg on Capillary Perfusion Density, Acute Kidney Injury Stage, Cardiac Index, and the Intensive Care Unit Length of Stay in Septic Shock Patients After Resuscitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04156451
Enrollment
44
Registered
2019-11-07
Start date
2019-11-14
Completion date
2020-11-30
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Deresuscitation, Central Venous Pressure, Septic Shock, Furosemide

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).

Interventions

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

Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients

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

active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Capillary Perfusion Density7 daysCapillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Secondary

MeasureTime frameDescription
Acute Kidney Injury Stage7 daysAKI staging using KDIGO criteria every 24 hours during deresuscitation
Cardiac Index7 dayscardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation
Neutrophil Gelatinase-Associated lipocalin (NGAL)1st and 7th dayNGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation
Renal Resistive Index (RRI)1st and 7th dayRRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation
Length of ICU stay28 dayslength of ICU stay in days during and after deresuscitation

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026