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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Septic Shock

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Central Venous Pressure 8 - 10 mmHg<br>Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached | Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg<br>* Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients<br>|
| Experimental: Central Venous Pressure 0 - 4 mmHg<br>Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached | Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg<br>* active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary Perfusion Density | Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation | 7 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deresuscitation, Central Venous Pressure, Septic Shock, Furosemide