NCT04104425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

September 24, 2019

Last Update Submit

July 18, 2023

Conditions

Patient Compliance

Outcome Measures

Primary Outcomes (1)

  • 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

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients presenting with acute gastrointestinal bleeding, inclusive of both upper and lower sources
  • Patients ≥18 years old

You may not qualify if:

  • Patients with tumor bleeding
  • patients with post procedure or surgical site bleeding
  • patients with active systemic infection
  • patients wit post-cardiopulmonary resuscitation state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 18776982RESULT

  • 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.

    PMID: 25936479RESULT

  • 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.

    PMID: 24813902RESULT

  • 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.

    PMID: 26113379RESULT

  • 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.

    PMID: 26837207RESULT

  • 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.

    PMID: 29872331RESULT

  • 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.

    PMID: 22473257RESULT

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal invistigator

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

January 15, 2020

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

EG(1)