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NCT Number: NCT04156451

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

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

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

Procedure

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

Primary outcomes

  1. Capillary Perfusion Density

    Time frame: 7 days

    Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Secondary outcomes

  1. Acute Kidney Injury Stage

    Time frame: 7 days

    AKI staging using KDIGO criteria every 24 hours during deresuscitation

  2. Cardiac Index

    Time frame: 7 days

    cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation

  3. Neutrophil Gelatinase-Associated lipocalin (NGAL)

    Time frame: 1st and 7th day

    NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation

  4. Renal Resistive Index (RRI)

    Time frame: 1st and 7th day

    RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation

  5. Length of ICU stay

    Time frame: 28 days

    length of ICU stay in days during and after deresuscitation

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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