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

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

2017-12-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Heading

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Detailed Description

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Conditions

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Cirrhotics With 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 SLED

Group Type EXPERIMENTAL

Early SLED

Intervention Type BIOLOGICAL

withing 6 to 12 hours

Late SLED

Group Type ACTIVE_COMPARATOR

Late SLED

Intervention Type BIOLOGICAL

when absolute indications will meet

Interventions

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Early SLED

withing 6 to 12 hours

Intervention Type BIOLOGICAL

Late SLED

when absolute indications will meet

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No