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Trial record 12 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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

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ClinicalTrials.gov Identifier: NCT04156451
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

Tracking Information
First Submitted Date  ICMJE November 1, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date  ICMJE November 8, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Capillary Perfusion Density [ Time Frame: 7 days ]
Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04156451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Acute Kidney Injury Stage [ Time Frame: 7 days ]
    AKI staging using KDIGO criteria every 24 hours during deresuscitation
  • Cardiac Index [ Time Frame: 7 days ]
    cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation
  • Neutrophil Gelatinase-Associated lipocalin (NGAL) [ Time Frame: 1st and 7th day ]
    NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation
  • Renal Resistive Index (RRI) [ Time Frame: 1st and 7th day ]
    RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation
  • Length of ICU stay [ Time Frame: 28 days ]
    length of ICU stay in days during and after deresuscitation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE
  • Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg
    Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients
  • Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg
    active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients
Study Arms  ICMJE
  • Active Comparator: Central Venous Pressure 8 - 10 mmHg
    Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached
    Intervention: Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg
  • Experimental: Central Venous Pressure 0 - 4 mmHg
    Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached
    Intervention: Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dita Aditianingsih, M.D, Ph.D +628151819244 ditaaditiaa@gmail.com
Contact: Yohanes W.H. George, M.D. +628121032069 yohanesgeorge@yahoo.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04156451
Other Study ID Numbers  ICMJE IndonesiaUAnes040
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dita Aditianingsih, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indonesia University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP