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

Indonesia University44 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Septic Shock

Interventions

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

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 mmHgPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Capillary Perfusion Density

Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Time frame: 7 days

Secondary Outcomes

Acute Kidney Injury Stage

AKI staging using KDIGO criteria every 24 hours during deresuscitation

Time frame: 7 days

Cardiac Index

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

Time frame: 7 days

Neutrophil Gelatinase-Associated lipocalin (NGAL)

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

Time frame: 1st and 7th day

Renal Resistive Index (RRI)

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

Time frame: 1st and 7th day

Length of ICU stay

length of ICU stay in days during and after deresuscitation

Time frame: 28 days

Data from ClinicalTrials.gov

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