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Clinical Trials/NCT04156451
NCT04156451
Completed
Not Applicable

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

Indonesia University1 site in 1 country44 target enrollmentStarted: November 14, 2019Last updated:
ConditionsSeptic Shock

Overview

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Capillary Perfusion Density

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Capillary Perfusion Density

Time Frame: 7 days

Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Secondary Outcomes

  • Cardiac Index(7 days)
  • Neutrophil Gelatinase-Associated lipocalin (NGAL)(1st and 7th day)
  • Renal Resistive Index (RRI)(1st and 7th day)
  • Acute Kidney Injury Stage(7 days)
  • Length of ICU stay(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dita Aditianingsih

MD, PhD, Anesthesiologist Consultant

Indonesia University

Study Sites (1)

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