Anemia and Duration of Mechanical Ventilation

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05382065
Collaborator
(none)
250
1
16.8
14.9

Study Details

Study Description

Brief Summary

In mechanically ventilated patients in intensive care unit, anemia is commonly seen and it is probably associated with adverse outcomes including mortality. We aim to investigate the impact of duration of anemia and the duration of mechanical ventilation as well as clinical outcomes in critically ill patients in intensive care unit who required ventilatory support

96 hr.

Detailed Description

Anemia is one of the most common conditions encountered critically ill patients. Various mechanisms can put these patients at risk of anemia including gastrointestinal hemorrhage, iron deficiency, inflammation and infection, stress, and multiple blood testing. Anemia can affect cardiopulmonary function as depletion in oxygen content in body. In mechanically ventilated patients, anemia is associated with increased duration of mechanical ventilation, increased length of stay, and possibly increased mortality. Some research suggested that hemoglobin level <8.5 g/dl was a potential risk factor for adverse outcome in critically ill patients required mechanical ventilation >96 hr. However, most researches focused on hemoglobin levels and the associated adverse events in mechanically ventilated patients. To the best of our knowledge, there are few studies reported the impact of the duration of anemia and the clinical outcomes in these patients. We hypothesize that the short duration of anemia developed in mechanically ventilated patients has no effect on duration of mechanical ventilation. We, therefore, aim to investigate the impact of the duration of anemia on duration of mechanical ventilation in critically ill patients required ventilatory support

96 hours.

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Correlation Between Period of Anemia and Duration of Mechanical Ventilation in Patients Admitted to the Surgical Intensive Care Unit
Actual Study Start Date :
Jul 8, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Duration of mechanical ventilation [28 days after initiation of ventilatory support]

    Days patients received mechanical ventilation

Secondary Outcome Measures

  1. Duration of anemia [28 days after initiation of ventilatory support]

    Days patients had hemoglobin level <8 g/dl while they were on ventilatory support

  2. Cardiovascular dysfunction [28 days after initiation of ventilatory support]

    SOFA cardiovascular component equal to 1, 3, or 4

  3. Respiratory dysfunction [28 days after initiation of ventilatory support]

    SOFA respiratory component >1

  4. Renal dysfunction [28 days after initiation of ventilatory support]

    SOFA respiratory component >1

  5. Gastrointestinal dysfunction [28 days after initiation of ventilatory support]

    SOFA gastrointestinal component >1

  6. Hematologic dysfunction [28 days after initiation of ventilatory support]

    SOFA hematologic component >1

  7. ICU length of stay [Up to 90 days following inclusion]

    Duration from ICU admission to ICU discharge

  8. Hospital length of stay [Up to 90 days following inclusion]

    Duration from hospital admission to hospital discharge

  9. ICU mortality [Up to 90 days following inclusion]

    Status at ICU discharge either alive or deceased

  10. Hospital mortality [Up to 90 days following inclusion]

    Status at hospital discharge either alive or deceased

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients whose age of equal or more than 18 years old

  • Patients admitted to the surgical intensive care unit during the study period

  • Patients required ventilatory support with invasive mechanical ventilation for more than 96 hours

Exclusion Criteria:
  • Patients whose data regarding time of beginning or ending of ventilatory support missed

  • Patients who are previously included in this study and are re-admitted

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Noi Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Annop Piriyapatsom, MD, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Annop Piriyapatsom, MD, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier:
NCT05382065
Other Study ID Numbers:
  • 255/2565(IRB3)
First Posted:
May 19, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Annop Piriyapatsom, MD, Associate Professor, Mahidol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022