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

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg
Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Deresuscitation, Central Venous Pressure, Septic Shock, Furosemide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rumah Sakit Cipto MangunkusumoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Central Venous Pressure 8 - 10 mmHg

Central Venous Pressure 0 - 4 mmHg

Arm Description

Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached

Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached

Outcomes

Primary Outcome Measures

Capillary Perfusion Density
Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2019
Last Updated
October 26, 2020
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04156451
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Deresuscitation, Central Venous Pressure, Septic Shock, Furosemide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Central Venous Pressure 8 - 10 mmHg
Arm Type
Active Comparator
Arm Description
Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached
Arm Title
Central Venous Pressure 0 - 4 mmHg
Arm Type
Experimental
Arm Description
Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached
Intervention Type
Procedure
Intervention Name(s)
Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg
Intervention Description
Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients
Intervention Type
Procedure
Intervention Name(s)
Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg
Intervention Description
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 Outcome Measure Information:
Title
Capillary Perfusion Density
Description
Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Acute Kidney Injury Stage
Description
AKI staging using KDIGO criteria every 24 hours during deresuscitation
Time Frame
7 days
Title
Cardiac Index
Description
cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation
Time Frame
7 days
Title
Neutrophil Gelatinase-Associated lipocalin (NGAL)
Description
NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation
Time Frame
1st and 7th day
Title
Renal Resistive Index (RRI)
Description
RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation
Time Frame
1st and 7th day
Title
Length of ICU stay
Description
length of ICU stay in days during and after deresuscitation
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dita Aditianingsih, M.D, Ph.D
Phone
+628151819244
Email
ditaaditiaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yohanes W.H. George, M.D.
Phone
+628121032069
Email
yohanesgeorge@yahoo.com
Facility Information:
Facility Name
Rumah Sakit Cipto Mangunkusumo
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dita Aditianingsih, M.D., Ph.D
Phone
+628151819244
Email
ditaaditiaa@gmail.com
First Name & Middle Initial & Last Name & Degree
Dita Aditianingsih, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients

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