Role of Blood Lactate Level in Prediction of Outcome of Cirrhotic Patients at The Intensive Care Unit

November 2, 2023 updated by: Hania Atef Mohamed Abdellatif, Assiut University
  1. Determine in-hospital and 28-days mortality rates of critically-ill cirrhotic patients admitted to ICU
  2. Evaluate the role of (blood lactate level, lactate/albumin ratio, lactate/bilirubin index and MELD-lactate score) in prediction of mortality compared to other non- lactate containing scores.
  3. Study predictors of in-hospital and 28-mortality in these patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Liver cirrhosis is a major health problem, which causes high mortality and economic burden worldwide. A large number of liver cirrhosis patients are prone to acute decompensation with organ failure, thus leading them to be admitted to intensive care unit (ICU).

Though liver cirrhosis patients have improved outcomes in ICU over the past decade, the prognosis for those patients remains poor, with in-hospital mortality. Assessment of prognosis, especially in patients with cirrhosis at the ICU, is of importance in order to guide therapeutic measures and improve their outcome.

Many prognostic scores are used to help predicting complications, expected survival and estimate the risk of various medical interventions in these patients as CTP, MELD, CLIF-C OF, CLIF-C AD and CLIF-C ACLF scores. Although these models are non-invasive, they have certain deficiencies as they don't consider other conditions that are associated with poor prognosis as poor tissue perfusion in critically-ill cirrhotic patients.

Lactate is a marker of metabolic changes resulting from tissue hypoxia or stress caused by the release of adrenaline. It was used to improve the prediction of short-term mortality of critically ill patients at ICU. Little is known about role of blood lactate in prediction of prognosis of critically ill Egyptian cirrhotic patients at ICU. Therefore, the investigators will conduct their study to shed some light on this topic.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Cirrhotic patients who are at least 18 years old at their first ICU admission in Al-Rajhy University Hospital (according to the established admission policy) and stay more than 24 h will be included.

Description

Inclusion Criteria:

  • Cirrhotic patients who are at least 18 years old at their first ICU admission in Al-Rajhy University Hospital (according to the established admission policy) and stay more than 24 h will be included.

Exclusion Criteria:

  • 1) Patients admitted for liver transplantation.
  • 2) Patients whose blood lactate data is lost at 24 hours from ICU admission.
  • 3) Patients taking drugs that increase level of serum lactate as metformin , acetaminophen, linezolid, epinephrine, beta2 agonists, propofol, nucleoside reverse transcriptase inhibitors (NRTIs) as lamivudine and abacavir , and theophylline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the hospital and 28-days mortality rates in critically-ill cirrhotic patients admitted to ICU of Al-Rajhy Universty Hospital.
Time Frame: within 28 days of patients' admission to the Intensive Care Unit.
1) To determine the hospital and 28-days mortality rates in critically-ill cirrhotic patients admitted to the Intensive Care Unit of Al-Rajhy Universty Hospital.
within 28 days of patients' admission to the Intensive Care Unit.
To evaluate the role of blood lactate level in prediction of 28-days mortality in critically-ill cirrhotic patients.
Time Frame: Blood lactate level will be estimated on the first day of Patients' admission to the ICU.
Blood lactate level (mmol/L)
Blood lactate level will be estimated on the first day of Patients' admission to the ICU.
To evaluate the role of lactate/Albumin ratio in prediction of 28-days mortality in critically-ill cirrhotic patients.
Time Frame: Lactate/Albumin ratio will be calculated on the first day of Patients' admission to the ICU.
Lactate/Albumin ratio (L/A ratio: albumin in (g/L) compared to lactate (mmol/L)).
Lactate/Albumin ratio will be calculated on the first day of Patients' admission to the ICU.
To evaluate the role of lactate/bilirubin index in prediction of 28-days mortality in critically-ill cirrhotic patients.
Time Frame: Lactate bilirubin index will be calculated on the first day of Patients' admission to the ICU.
Lactate bilirubin index ( lactate in mmol/L , bilirubin in umol/l ) : will be calculated as follows : [1000 × lactate (mmol/L) × bilirubin (µmol/L)]/2 (Chen et al., 2021).
Lactate bilirubin index will be calculated on the first day of Patients' admission to the ICU.
To evaluate the role of MELD-Lactate score in prediction of 28-days mortality in critically-ill cirrhotic patients.
Time Frame: MELD-Lactate score will be calculated on the first day of Patients' admission to the ICU.
MELD-Lactate score: (Moreau et al., 2013) will be calculated as follows: 0.251 + 5.5257 × sqrt (lactate mmol/L ) + 0.338 × MELD (Sarmast et al., 2020).
MELD-Lactate score will be calculated on the first day of Patients' admission to the ICU.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between blood lactate level and type and number of organ failure.
Time Frame: Within 28 days of Patients' admission to the Intensive Care Unit.
Correlation between blood lactate level and type and number of organ failure.
Within 28 days of Patients' admission to the Intensive Care Unit.
Correlation between blood lactate level and duration of hospital stay.
Time Frame: Within 28 days of Patients' admission to the Intensive Care Unit.
Correlation between blood lactate level and duration of hospital stay.
Within 28 days of Patients' admission to the Intensive Care Unit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lactate in Cirrhotic Patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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