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

NCT06121908 | Unknown

• 1 other identifier: Lactate in Cirrhotic Patients
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Determine in-hospital and 28-days mortality rates of critically-ill cirrhotic patients admitted to ICU
2. 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. 3.Study predictors of in-hospital and 28-mortality in these patients.

Conditions

Liver Cirrhosis

Keywords

Lactate

Outcome Measures

Primary Outcomes (5)

• To determine the hospital and 28-days mortality rates in critically-ill cirrhotic patients admitted to ICU of Al-Rajhy Universty Hospital.

  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.

  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.

  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.

  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.

  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 Outcomes (2)

• 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.

  Within 28 days of Patients' admission to the Intensive Care Unit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \) Patients admitted for liver transplantation.
• \) Patients whose blood lactate data is lost at 24 hours from ICU admission.
• \) 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Li X, Gong M, Fu S, Zhang J, Wu S. Establishment of MELD-lactate clearance scoring system in predicting death risk of critically ill cirrhotic patients. BMC Gastroenterol. 2022 Jun 3;22(1):280. doi: 10.1186/s12876-022-02351-5.

  PMID: 35658837 BACKGROUND

• Drolz A, Horvatits T, Rutter K, Landahl F, Roedl K, Meersseman P, Wilmer A, Kluwe J, Lohse AW, Kluge S, Trauner M, Fuhrmann V. Lactate Improves Prediction of Short-Term Mortality in Critically Ill Patients With Cirrhosis: A Multinational Study. Hepatology. 2019 Jan;69(1):258-269. doi: 10.1002/hep.30151. Epub 2018 Dec 17.

  PMID: 30070381 BACKGROUND

• Moon AM, Singal AG, Tapper EB. Contemporary Epidemiology of Chronic Liver Disease and Cirrhosis. Clin Gastroenterol Hepatol. 2020 Nov;18(12):2650-2666. doi: 10.1016/j.cgh.2019.07.060. Epub 2019 Aug 8.

  PMID: 31401364 BACKGROUND

• Saliba F, Ichai P, Levesque E, Samuel D. Cirrhotic patients in the ICU: prognostic markers and outcome. Curr Opin Crit Care. 2013 Apr;19(2):154-60. doi: 10.1097/MCC.0b013e32835f0c17.

  PMID: 23426137 BACKGROUND

• Weil D, Levesque E, McPhail M, Cavallazzi R, Theocharidou E, Cholongitas E, Galbois A, Pan HC, Karvellas CJ, Sauneuf B, Robert R, Fichet J, Piton G, Thevenot T, Capellier G, Di Martino V; METAREACIR Group. Prognosis of cirrhotic patients admitted to intensive care unit: a meta-analysis. Ann Intensive Care. 2017 Dec;7(1):33. doi: 10.1186/s13613-017-0249-6. Epub 2017 Mar 21.

  PMID: 28321803 BACKGROUND

• Fuhrmann V, Whitehouse T, Wendon J. The ten tips to manage critically ill patients with acute-on-chronic liver failure. Intensive Care Med. 2018 Nov;44(11):1932-1935. doi: 10.1007/s00134-018-5078-z. Epub 2018 Jan 31. No abstract available.

  PMID: 29387913 BACKGROUND

• Costa E Silva PP, Codes L, Rios FF, Esteve CP, Valverde Filho MT, Lima DOC, de Almeida Filho GF, Morais MCA, Lima BC, Chagas PBO, Boa-Sorte N, Bittencourt PL. Comparison of General and Liver-Specific Prognostic Scores in Their Ability to Predict Mortality in Cirrhotic Patients Admitted to the Intensive Care Unit. Can J Gastroenterol Hepatol. 2021 Sep 24;2021:9953106. doi: 10.1155/2021/9953106. eCollection 2021.

  PMID: 34608435 BACKGROUND

• Sarmast N, Ogola GO, Kouznetsova M, Leise MD, Bahirwani R, Maiwall R, Tapper E, Trotter J, Bajaj JS, Thacker LR, Tandon P, Wong F, Reddy KR, O'Leary JG, Masica A, Modrykamien AM, Kamath PS, Asrani SK. Model for End-Stage Liver Disease-Lactate and Prediction of Inpatient Mortality in Patients With Chronic Liver Disease. Hepatology. 2020 Nov;72(5):1747-1757. doi: 10.1002/hep.31199.

  PMID: 32083761 BACKGROUND

• Nie Y, Zhang Y, Liu LX, Zhu X. Serum Lactate Level Predicts Short-Term and Long-Term Mortality of HBV-ACLF Patients: A Prospective Study. Ther Clin Risk Manag. 2020 Sep 10;16:849-860. doi: 10.2147/TCRM.S272463. eCollection 2020.

  PMID: 32982257 BACKGROUND

• Zanza C, Facelli V, Romenskaya T, Bottinelli M, Caputo G, Piccioni A, Franceschi F, Saviano A, Ojetti V, Savioli G, Longhitano Y. Lactic Acidosis Related to Pharmacotherapy and Human Diseases. Pharmaceuticals (Basel). 2022 Nov 30;15(12):1496. doi: 10.3390/ph15121496.

  PMID: 36558947 BACKGROUND

• Chen Xiao-Fu, Zhao Yuan, Chen Wei-Zhen, et al., Lactate and Bilirubin Index: A New Indicator to Predict Critically Ill Cirrhotic Patients' Prognosis, Canadian Journal of Gastroenterology and Hepatology,vol. 2021, Article ID 6624177, 7 pages,2021.

  BACKGROUND

• Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013 Jun;144(7):1426-37, 1437.e1-9. doi: 10.1053/j.gastro.2013.02.042. Epub 2013 Mar 6.

  PMID: 23474284 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hania A Abdellatif

CONTACT

+201024917748; haniaabdellatif@gmail.com

Ghada M Galal

CONTACT

+201002623401; G.refat@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 8, 2023
• Study Start: November 15, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 1, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11