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

Not yet recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT06121908
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-10-20
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Study Start: 2023-11-15
• Primary Completion: 2024-10-31
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the hospital and 28-days mortality rates in critically-ill cirrhotic patients admitted to ICU of Al-Rajhy Universty Hospital.	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.
To evaluate the role of lactate/bilirubin index in prediction of 28-days mortality in critically-ill cirrhotic patients.	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).
To evaluate the role of blood lactate level in prediction of 28-days mortality in critically-ill cirrhotic patients.	Blood lactate level will be estimated on the first day of Patients' admission to the ICU.	Blood lactate level (mmol/L)
To evaluate the role of lactate/Albumin ratio in prediction of 28-days mortality in critically-ill cirrhotic patients.	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)).
To evaluate the role of MELD-Lactate score in prediction of 28-days mortality in critically-ill cirrhotic patients.	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).

Secondary Outcome Measures

Name	Time	Method
Correlation between blood lactate level and duration of hospital stay.	Within 28 days of Patients' admission to the Intensive Care Unit.	Correlation between blood lactate level and duration of hospital stay.
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 type and number of organ failure.