Patient ComplianceNCT04104425
Lactate Level and Gastrointestinal Bleeding
An observational study of Patient Compliance, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Compliance
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 15 Sep 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with acute gastrointestinal bleeding to emergency department of Assiut University hospital
Who may be able to join
- Patients presenting with acute gastrointestinal bleeding, inclusive of both upper and lower sources
- Patients ≥18 years old
Who cannot join
- Patients with tumor bleeding
- patients with post procedure or surgical site bleeding
- patients with active systemic infection
- patients wit post-cardiopulmonary resuscitation state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Compliance
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start15 Jan 2020
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies 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
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hekmat Nashat Shawky Zakhary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104425
- Sponsor's protocol ID
- LA in GIB
- Status last verified
- Jul 2023
- First submitted
- 24 Sep 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18776982Musikatavorn 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.
PubMed 25936479Shah 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.
PubMed 24813902El-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.
PubMed 26113379Wada 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.
PubMed 26837207Shrestha 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.
PubMed 29872331Hernandez 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.
PubMed 22473257
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lactate Level in Prediction of Patients'Acute Gastrointestinal Bleeding Admissions to Intensive Care Unit, Interventions and Short Term Outcomes
- ClinicalTrials.gov ID
- NCT04104425
- Acronym / sponsor ID
- LA in GIB
- Conditions
- Patient Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 26 Sep 2019 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute gastrointestinal bleeding to emergency department of Assiut University hospital
Key inclusion criteria (2 listed)
- Patients presenting with acute gastrointestinal bleeding, inclusive of both upper and lower sources
- Patients ≥18 years old
Key exclusion criteria (4 listed)
- Patients with tumor bleeding
- patients with post procedure or surgical site bleeding
- patients with active systemic infection
- patients wit post-cardiopulmonary resuscitation state
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Results publication: PubMed 18776982Zippi 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.
- Results publication: PubMed 25936479Musikatavorn 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.
- Results publication: PubMed 24813902Shah 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.
- Results publication: PubMed 26113379El-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.
- Results publication: PubMed 26837207Wada 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.
- Results publication: PubMed 29872331Shrestha 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.
- Results publication: PubMed 22473257Hernandez 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Compliance, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). 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 NCT04104425, which also lists 7 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 19 Jul 2023.