20% Albumin vs. Balanced Salt Solution as Resuscitation Fluid in Cirrhosis

Status Recruiting

Clinical Trial Summary

Patients with cirrhosis patients have a high incidence of sepsis which can trigger decompensation and may result in prolonged hospital stay and increased mortality. About 30%-50% admissions of patients with cirrhosis have sepsis at presentation and about 15% patients admitted to hospital develop sepsis during the hospital stay . After infection develops, the patient may develop acute kidney injury (AKI), shock, encephalopathy or disseminated intravascular coagulation (DIC) further decreasing the chances of survival. In fact, sepsis in patients with cirrhosis is associated with 15% in-hospital mortality, approximately double that of patients without sepsis. So, sepsis is directly responsible for 30-50% of deaths in cirrhosis . Therefore, it is critical to manage sepsis early and appropriately in cirrhosis to reduce the complications and mortality. Early administration of fluids, source control and empirical antibiotics along with vasopressors if refractory shock are essential components of treatment in all patients with sepsis. Currently, the most accepted strategy for early sepsis management is a combination of early goal directed therapy (EGDT) and physiological parameters, such as urine output, lactate clearance, and administration of antibiotics, within 1 hour of presentation . The use of central venous pressure assessment is fallacious for gauging adequacy of fluid resuscitation in cirrhosis, and the difficulty of performing echocardiographic assessments in the setting of ascites and cirrhotic cardiomyopathy is also well described .

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05441878
Study type	Interventional
Source	Postgraduate Institute of Medical Education and Research
Contact	Madhumita Premkumar, DM
Phone	01722756344
Email	drmadhumitap@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	August 15, 2020
Completion date	December 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05793983` - S100A8/A9 and Innate Immunity in Liver Disease
Completed	`NCT04604860` - Use of EL-FIT App to Promote Physical Activity	N/A
Recruiting	`NCT05928624` - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients	N/A
Active, not recruiting	`NCT01438970` - Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function	Phase 2
Recruiting	`NCT05998330` - LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease	N/A
Completed	`NCT04581369` - Cirrhosis Medical Home	N/A
Withdrawn	`NCT04244877` - Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility	Phase 3
Recruiting	`NCT04588077` - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis	Phase 4
Recruiting	`NCT05538962` - Longitudinal Monitoring of Inflammation in Cirrhosis	N/A
Completed	`NCT04082780` - Rifamycin in Minimal Hepatic Encephalopathy	Phase 2
Completed	`NCT03850977` - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Active, not recruiting	`NCT03736265` - Carvedilol for Prevention of Esophageal Varices Progression	N/A
Recruiting	`NCT04530760` - Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Recruiting	`NCT05093218` - Effect of Branch Chain Amino Acid Therapy on Sarcopenia in Children With Chronic Liver Disease.	N/A
Recruiting	`NCT03437876` - Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis	N/A
Recruiting	`NCT05604274` - Longitudinal Monitoring of Stool Characteristics
Recruiting	`NCT04867954` - Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
Completed	`NCT04643795` - Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects	Phase 1
Active, not recruiting	`NCT02344680` - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed	`NCT04121520` - Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

20% Albumin vs. Balanced Salt Solution as Resuscitation Fluid in Cirrhosis With Sepsis Induced Hypotension

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms