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Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI

NCT ID: NCT03343340

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2018-09-25

Brief Summary

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Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. 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, 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.

Detailed Description

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Conditions

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Septic Shock and Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early CRRT

Early Continous Renal Replacement Therapy within 6 hours + Standard Medical Therapy

Group Type EXPERIMENTAL

Early CRRT

Intervention Type OTHER

Continous Renal Replacement Therapy

Standard Medical Therapy

Intervention Type OTHER

Standard Medical Therapy

Late CRRT

Late Continous Renal Replacement Therapy + Standard Medical Therapy

Group Type ACTIVE_COMPARATOR

Late CRRT

Intervention Type OTHER

Continous Renal Replacement Therapy

Standard Medical Therapy

Intervention Type OTHER

Standard Medical Therapy

Interventions

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Early CRRT

Continous Renal Replacement Therapy

Intervention Type OTHER

Late CRRT

Continous Renal Replacement Therapy

Intervention Type OTHER

Standard Medical Therapy

Standard Medical Therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Patients with ACLF defined based on APASL criteria with septic shock associated AKI

Exclusion Criteria

* 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 with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr Rakhi Maiwall, MD,DM

Role: CONTACT

Phone: 01146300000

Email: [email protected]

References

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Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

Reference Type DERIVED
PMID: 36416787 (View on PubMed)

Other Identifiers

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ILBS-CRRT-01

Identifier Type: -

Identifier Source: org_study_id