Lactate Level and Gastrointestinal Bleeding

July 18, 2023 updated by: Hekmat Nashat Shawky Zakhary, Assiut University

Role of Lactate Level in Prediction of Patients'Acute Gastrointestinal Bleeding Admissions to Intensive Care Unit, Interventions and Short Term Outcomes

Acute gastrointestinal bleeding is a common emergency with significant morbidity, mortality, and cost. Appropriate risk stratification of patients presenting with acute gastrointestinal bleeding aids in the triage of patients to determine need for hospital admission and the need for emergency endoscopic intervention. Increased blood lactate levels are common in critically ill patients. Our study will evaluate the usefulness of lactate measurements on resources utilisation ( intensive care unit admission, length of hospital stay) and other patient-oriented outcomes ( need for transfusion and endoscopy) in patients with acute gastrointestinal bleeding.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

      • Assiut, Egypt
        • Assiut university

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients presenting with acute gastrointestinal bleeding to emergency department of Assiut University hospital

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

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
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
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
2 years

Collaborators and Investigators

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

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 (Actual)

January 15, 2020

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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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