Volume Resuscitation in Cirrhosis With Sepsis Induced Hypotension

NCT05059795 | Completed

• 1 other identifier: Im/2019/2917
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

In critically ill patients with liver disease like cirrhosis or ACLF, fluid therapy needs to be instituted after identification of patients who will be fluid responsive and initiate appropriate inotropes early to prevent the mortality associated with fluid overload. The parameters and methodology used for assessing fluid responsiveness have been studied earlier, but the optimum method is not established. Existing recommendations based on data regarding fluid responsiveness and choice of fluid for resuscitation from intensive care units in general cannot be applied to those with liver disease as the hemodynamic alterations that occur with liver disease, presence of hypoalbuminemia at baseline and presence of cardiac dysfunction interfere with the conventional methods of fluid status assessment, fluid responsiveness as well as the response to different types of resuscitation fluids. Therefore the investigators attempt to compare various methods to estimate current intravascular volume status of patient which could be helpful in guiding fluid therapy.

Conditions

Cirrhosis, Liver; Sepsis; Acute on Chronic Liver Failure

Keywords

Resuscitation in cirrhosis; Inferior vena cava dynamics; Central Venous Pressure in cirrhosis; Lactate clearance in cirrhosis; Acute-on-chronic liver failure; Sepsis in Cirrhosis; Shock in ACLF and Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Achievement of Mean Arterial pressure >65 mmHg

  At the end of 4 hours since admission (time zero)

Secondary Outcomes (29)

• Requirement of vasopressors

  At the end of 4 hours of admission

• Requirement of vasopressors

  At the end of 24 hours of admission

• Volume of fluid infused

  At the end of 4 hours of admission

• Volume of fluid infused

  At the end of 24 hours of admission

• Volume of fluid infused

  At the end of 36 hours of admission

Study Arms (1)

Cirrhosis/ACLF of any etiology

Drug: Albumin + electrolyte solution; Diagnostic Test: POCUS guided fluid resuscitation

Interventions

Albumin + electrolyte solution DRUG

Type of resuscitation fluid, dose and use of inotrope

Also known as: Crystalloid

Cirrhosis/ACLF of any etiology

POCUS guided fluid resuscitation DIAGNOSTIC_TEST

Conventional goal directed therapy

Cirrhosis/ACLF of any etiology

Eligibility Criteria

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

Study Population

Patients 18-65 years age with cirrhosis of any etiology now presenting with sepsis induced hypotension

You may qualify if:

• Clinical/Imaging or Biopsy proven liver cirrhosis of any etiology
• Hypotension (MAP \<65mmHg or SBP \<90mmHg)
• yrs of age

You may not qualify if:

• Already received colloid or 2 litres of fluid within the first 2 hours of presentation, without echocardiographic assessment.
• Already on vasopressors/inotropes
• Severe pre-existing cardiopulmonary disease
• Acute Respiratory Distress Syndrome (ARDS)
• Active bleeding like variceal bleed 28
• Cerebrovascular events
• Chronic renal disease - End Stage Renal Disease (ESRD)/ patient on renal replacement therapy
• Admission to ICU following liver transplantation, burns, cardiac surgery
• Brain death or likely brain death within 24 hours
• Previous adverse reaction to human albumin solution
• Pregnant or lactating women
• Informed consent refused by patient or attendants

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (12)

• Moreau R, Hadengue A, Soupison T, Kirstetter P, Mamzer MF, Vanjak D, Vauquelin P, Assous M, Sicot C. Septic shock in patients with cirrhosis: hemodynamic and metabolic characteristics and intensive care unit outcome. Crit Care Med. 1992 Jun;20(6):746-50. doi: 10.1097/00003246-199206000-00008.

  PMID: 1597026 BACKGROUND

• ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.

  PMID: 25272316 BACKGROUND

• Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331.

  PMID: 18628220 BACKGROUND

• Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will This Hemodynamically Unstable Patient Respond to a Bolus of Intravenous Fluids? JAMA. 2016 Sep 27;316(12):1298-309. doi: 10.1001/jama.2016.12310.

  PMID: 27673307 BACKGROUND

• Velissaris D, Pierrakos C, Scolletta S, De Backer D, Vincent JL. High mixed venous oxygen saturation levels do not exclude fluid responsiveness in critically ill septic patients. Crit Care. 2011 Jul 26;15(4):R177. doi: 10.1186/cc10326.

  PMID: 21791090 BACKGROUND

• Lee YK, Hwang SY, Shin TG, Jo IJ, Suh GY, Jeon K. Prognostic Value of Lactate and Central Venous Oxygen Saturation after Early Resuscitation in Sepsis Patients. PLoS One. 2016 Apr 7;11(4):e0153305. doi: 10.1371/journal.pone.0153305. eCollection 2016.

  PMID: 27054713 BACKGROUND

• Lee J, de Louw E, Niemi M, Nelson R, Mark RG, Celi LA, Mukamal KJ, Danziger J. Association between fluid balance and survival in critically ill patients. J Intern Med. 2015 Apr;277(4):468-77. doi: 10.1111/joim.12274. Epub 2014 Jun 27.

  PMID: 24931482 BACKGROUND

• Sefidbakht S, Assadsangabi R, Abbasi HR, Nabavizadeh A. Sonographic measurement of the inferior vena cava as a predictor of shock in trauma patients. Emerg Radiol. 2007 Jul;14(3):181-5. doi: 10.1007/s10140-007-0602-4. Epub 2007 Jun 1.

  PMID: 17541661 BACKGROUND

• Premkumar M, Rangegowda D, Kajal K, Khumuckham JS. Noninvasive estimation of intravascular volume status in cirrhosis by dynamic size and collapsibility indices of the inferior vena cava using bedside echocardiography. JGH Open. 2019 Mar 12;3(4):322-328. doi: 10.1002/jgh3.12166. eCollection 2019 Aug.

  PMID: 31406926 BACKGROUND

• Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.

  PMID: 20463176 BACKGROUND

• Du W, Liu DW, Wang XT, Long Y, Chai WZ, Zhou X, Rui X. Combining central venous-to-arterial partial pressure of carbon dioxide difference and central venous oxygen saturation to guide resuscitation in septic shock. J Crit Care. 2013 Dec;28(6):1110.e1-5. doi: 10.1016/j.jcrc.2013.07.049.

  PMID: 24216336 BACKGROUND

• Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11.

  PMID: 31342529 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Urine Samples

MeSH Terms

Conditions

Liver Cirrhosis; Sepsis; Acute-On-Chronic Liver Failure; Fibrosis

Interventions

Albumins; Crystalloid Solutions

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: September 28, 2021
• Study Start: February 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: August 10, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)