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Trial record 2 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT02937961
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.

Condition or disease Intervention/treatment Phase
Cirrhotics With Septic Shock and Acute Kidney Injury Biological: Early SLED Biological: Late SLED Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury -A Pilot Randomized Controlled Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Shock

Arm Intervention/treatment
Experimental: Early SLED Biological: Early SLED
withing 6 to 12 hours

Active Comparator: Late SLED Biological: Late SLED
when absolute indications will meet




Primary Outcome Measures :
  1. Transplant free survival in both groups [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Incidence of intradialytic hypotension in both groups [ Time Frame: 48 hours ]
  2. Hemodynamic stability in both groups [ Time Frame: 48 hours ]
  3. Dialysis efficiency as measured by Urea Reduction ratio in both groups [ Time Frame: 2 days ]
  4. Achievement of target ultrafiltration goals in both groups [ Time Frame: 48 hours ]
  5. Recovery in renal functions in both groups [ Time Frame: 14 days ]
    Recovery is defined as an increase in urine output to more than 400 ml/day

  6. Duration of Intensive Care Unit stay in both groups [ Time Frame: 28 days ]
  7. Duration of mechanical ventilation in both groups [ Time Frame: 28 days ]
  8. Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups [ Time Frame: 28 days ]
  9. Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores [ Time Frame: 28 days ]
  10. Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores [ Time Frame: 28 days ]
  11. Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups [ Time Frame: 6 hours ]
  12. Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups [ Time Frame: 12 hours ]
  13. Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups [ Time Frame: 24 hours ]
  14. Death related with renal failure in both groups [ Time Frame: 7 day ]
  15. Mortality due to renal failure related in both groups. [ Time Frame: 7 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients with Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.

Exclusion Criteria:

  • Patients with age less than 18 years
  • Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, Coronary Obstructive Pulmonary Disease)
  • Pregnancy
  • Chronic kidney disease on hemodialysis
  • Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-glomerulonephritis, interstitial nephritis or vasculitis
  • Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (serum potassium>6 meq/lt, metabolic acidosis ph<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
  • Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
  • Extremely moribund patients with an expected life expectancy of less than 24 hours
  • Failure to give informed consent from family members.
  • Hemodynamic instability requiring very high dose of vasopressors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937961


Contacts
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Contact: Dr Rakhi Maiwall, MD,DM 01146300000 rakhi_2011@yahoo.co.in

Locations
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India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02937961     History of Changes
Other Study ID Numbers: ILBS-Septic Shock-001
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Acute Kidney Injury
Shock
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Pathologic Processes
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation