Clinical trial NCT04104425: Lactate Level and Gastrointestinal Bleeding
Official title: Role of Lactate Level in Prediction of Patients'Acute Gastrointestinal Bleeding Admissions to Intensive Care Unit, Interventions and Short Term Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Compliance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with acute gastrointestinal bleeding to emergency department of Assiut University hospital

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
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