Clinical trial NCT04156451: Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Deresuscitation
Central Venous Pressure
Septic Shock
Furosemide
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Capillary Perfusion Density
timeFrame: 7 days
Secondary outcomes:
measure: Acute Kidney Injury Stage
timeFrame: 7 days
measure: Cardiac Index
timeFrame: 7 days
measure: Neutrophil Gelatinase-Associated lipocalin (NGAL)
timeFrame: 1st and 7th day
measure: Renal Resistive Index (RRI)
timeFrame: 1st and 7th day
measure: Length of ICU stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
References:
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