Liver CirrhosisNCT06121908
Role of Blood Lactate Level in Prediction of Outcome of Cirrhotic Patients at The Intensive Care Unit
An observational study of Liver Cirrhosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
- Determine in-hospital and 28-days mortality rates of critically-ill cirrhotic patients admitted to ICU
- 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.
- Study predictors of in-hospital and 28-mortality in these patients.
Read the 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.
- Conditions
- Liver Cirrhosis
- Keywords
- Lactate
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the hospital and 28-days mortality rates in critically-ill cirrhotic patients admitted to ICU of Al-Rajhy Universty Hospital.
- 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.
Measured: 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)
Measured: 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)).
Measured: 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).
Measured: 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).
Measured: 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.
Correlation between blood lactate level and type and number of organ failure.
Measured: 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 duration of hospital stay.
Measured: Within 28 days of Patients' admission to the Intensive Care Unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hania Atef Mohamed Abdellatif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121908
- Sponsor's protocol ID
- Lactate in Cirrhotic Patients
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35658837Drolz 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.
PubMed 30070381Moon 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.
PubMed 31401364Saliba 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.
PubMed 23426137Weil 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.
PubMed 28321803Fuhrmann 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.
PubMed 29387913Costa 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.
PubMed 34608435Sarmast 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.
PubMed 32083761Nie 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.
PubMed 32982257Zanza 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.
PubMed 36558947Chen 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.
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.
PubMed 23474284
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Blood Lactate Level in Prediction of Outcome of Cirrhotic Patients at The Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06121908
- Acronym / sponsor ID
- Lactate in Cirrhotic Patients
- Conditions
- Liver Cirrhosis
- Keywords
- Lactate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Determine in-hospital and 28-days mortality rates of critically-ill cirrhotic patients admitted to ICU
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
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)).
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).
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).
2 secondary outcomes
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 duration of hospital stay.
Time frame: Within 28 days of Patients' admission to the Intensive Care Unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 35658837Li 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.
- Background: PubMed 30070381Drolz 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.
- Background: PubMed 31401364Moon 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.
- Background: PubMed 23426137Saliba 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.
- Background: PubMed 28321803Weil 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.
- Background: PubMed 29387913Fuhrmann 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.
- Background: PubMed 34608435Costa 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.
- Background: PubMed 32083761Sarmast 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.
- Background: PubMed 32982257Nie 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.
- Background: PubMed 36558947Zanza 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.
- BackgroundChen 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: PubMed 23474284Moreau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hania A Abdellatif (+201024917748, haniaabdellatif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121908, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.