Impact of Continuous Renal Replacement Therapy on Systemic Hemodynamics and Lactate Clearance in Critically Ill Cirrhotics With Septic Shock.

NCT04949178 | Unknown

• 1 other identifier: ILBS-Cirrhosis-41
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Consecutive critically ill cirrhotics with septic shock and AKI who give written informed consent will be included in this prospective study. A blood and urine sample (\~10 ml) would be stored for assessing the serum cytokine profile, endotoxin levels, NT-Pro BNP, Troponin I levels, urine N-GAL before, 6 hours and at 24 hours after initiation of CRRT. 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 SVR, SVRI, global ejection fraction, extravascular lung water index and pulmonary vascular permeability index, CVP, IVC diameter and B-lines on ultrasound lung would be recorded. A record of the clearance of lactate at 6, 12 , 24 and daily till recovery or death would be performed. 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, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Improvement of SVR from baseline by 20% or above 600 and decrease in vasopressors at 24 hours after CRRT initiation.

  24 hours

Secondary Outcomes (5)

• Lactate clearance after CRRT initiation

  6 hours

• Lactate clearance after CRRT initiation

  12 hours

• Lactate clearance after CRRT initiation

  24 hours

• Incidence of renal recovery

  24 hours

• Incidence of dialysis associated complications (hypotension, bleeding, hypothermia, catheter-related blood stream infections would be recorded).

  24 hours

Study Arms (1)

Critically ill cirrhotics with septic shock and AKI undergoing CRRT

Consecutive critically ill cirrhotics with septic shock and AKI who give written informed consent will be included in this prospective study

Other: No intervention

Interventions

No intervention OTHER

This is an observational study.

Critically ill cirrhotics with septic shock and AKI undergoing CRRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill cirrhotics with septic shock and AKI undergoing CRRT

You may qualify if:

• Critically ill cirrhotics undergoing continuous renal replacement therapy.

You may not qualify if:

• 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
• 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.
• Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP\>=65 mm of Hg and having a serum lactate \>2 mmol/L despite adequate volume resuscitation.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood and urine sample (\~10 ml) would be stored for assessing the serum cytokine profile, endotoxin levels, NT-Pro BNP, Troponin I levels, urine N-GAL before, 6 hours and at 24 hours after initiation of CRRT.

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: June 25, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

IN (1)