- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04104425
Lactate Level and Gastrointestinal Bleeding
Role of Lactate Level in Prediction of Patients'Acute Gastrointestinal Bleeding Admissions to Intensive Care Unit, Interventions and Short Term Outcomes
Study Overview
Status
Conditions
Detailed Description
The present study is a prospective cross sectional study aimed to assess whether venous blood lactate on hospital presentation is predictive of need for interventions and short term outcomes (eg PRBC transfusion, ICU admission ) in patients with acute GIB who presented to ED of Assuit University hospital between September 2019 and June 2022. The study included 300 patients with acute GIB. Out of those patients; 200 patients had elevated blood lactate and 100 patients had normal blood lactate.
It was found that mean age of patients with elevated lactate was significantly higher in comparison to those with normal lactate. There were no significant differences between both groups as regard risk factors for bleeding (use of anti-coagulants, aspirin), use of NSAIDs was higher among patients with normal lactate while history of prior UGIB was higher among patients with elevated lactate. The most frequent presentations among the studied patients were hematemesis and melena.
Both groups had insignificant differences as regard laboratory data, endoscopic findings and interventions.
Patients with elevated lactate had prolonged hospital stay, higher frequency of blood transfusion, ICU admission and mortality in comparison to those with normal blood lactate.
Based on the current study, predictors of mortality among patients with UGIB were old age , LC, elevated lactate and variceal bleeding.
So we could say that elevated blood lactate can be predictive for interventions and short term outcomes in patients with acute GIB ,however, further and similar studies with multi-center settings would be more reliable and accurate.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt
- Assiut university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients presenting with acute gastrointestinal bleeding, inclusive of both upper and lower sources
- Patients ≥18 years old
Exclusion Criteria:
- Patients with tumor bleeding
- patients with post procedure or surgical site bleeding
- patients with active systemic infection
- patients wit post-cardiopulmonary resuscitation state
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The need for intensive care unit admissions, intervention and short term outcomes ( packed red blood cells transfusion) in patients with acute gastrointestinal bleeding and elevated lactate level
Time Frame: 2 years
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Assessment of role of elevated lactate level in predicting the need for intensive care unit admissions, emergency endoscopic intervention and packed red blood cells transfusion in patients with acute gastrointestinal bleeding
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2 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Musikatavorn K, Thepnimitra S, Komindr A, Puttaphaisan P, Rojanasarntikul D. Venous lactate in predicting the need for intensive care unit and mortality among nonelderly sepsis patients with stable hemodynamic. Am J Emerg Med. 2015 Jul;33(7):925-30. doi: 10.1016/j.ajem.2015.04.010. Epub 2015 Apr 10.
- Hernandez G, Bruhn A, Castro R, Regueira T. The holistic view on perfusion monitoring in septic shock. Curr Opin Crit Care. 2012 Jun;18(3):280-6. doi: 10.1097/MCC.0b013e3283532c08.
- Zippi M, Febbraro I, De Felici I, Mattei E, Traversa G, Occhigrossi G. [Diagnosis and treatment of bleeding peptic ulcer: our experience]. Clin Ter. 2008 Jul-Aug;159(4):249-55. Italian.
- Shah A, Chisolm-Straker M, Alexander A, Rattu M, Dikdan S, Manini AF. Prognostic use of lactate to predict inpatient mortality in acute gastrointestinal hemorrhage. Am J Emerg Med. 2014 Jul;32(7):752-5. doi: 10.1016/j.ajem.2014.02.010. Epub 2014 Feb 17.
- El-Kersh K, Chaddha U, Sinha RS, Saad M, Guardiola J, Cavallazzi R. Predictive Role of Admission Lactate Level in Critically Ill Patients with Acute Upper Gastrointestinal Bleeding. J Emerg Med. 2015 Sep;49(3):318-25. doi: 10.1016/j.jemermed.2015.04.008. Epub 2015 Jun 22.
- Wada T, Hagiwara A, Uemura T, Yahagi N, Kimura A. Early lactate clearance for predicting active bleeding in critically ill patients with acute upper gastrointestinal bleeding: a retrospective study. Intern Emerg Med. 2016 Aug;11(5):737-43. doi: 10.1007/s11739-016-1392-z. Epub 2016 Feb 2.
- Shrestha MP, Borgstrom M, Trowers EA. Elevated lactate level predicts intensive care unit admissions, endoscopies and transfusions in patients with acute gastrointestinal bleeding. Clin Exp Gastroenterol. 2018 May 23;11:185-192. doi: 10.2147/CEG.S162703. eCollection 2018.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LA in GIB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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