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AnemiaNCT05382065

Anemia and Duration of Mechanical Ventilation

An observational study of Anemia and Mechanical Ventilation, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Mechanical Ventilation, Critically Ill
How many people
236 participants
Where
1 siteThailand
Study dates
8 Jul 2022to 30 Apr 2024
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: Adult patients admitted to the surgical intensive care unit and required ventilatory support with invasive mechanical ventilation for more than 96 hours

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: The Correlation Between Period of Anemia and Duration of Mechanical Ventilation in Patients Admitted to the Surgical Intensive Care Unit

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.

Read the 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.

Keywords
Duration of mechanical ventilation, Duration of anemia, Intensive care unit, Mortality, Organ dysfunction
Medical subject headings
Anemia, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of mechanical ventilation

    Days patients received mechanical ventilation

    Measured: 28 days after initiation of ventilatory support

Secondary outcomes (10)

  1. Duration of anemia

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

    Measured: 28 days after initiation of ventilatory support

  2. Cardiovascular dysfunction

    SOFA cardiovascular component equal to 1, 3, or 4

    Measured: 28 days after initiation of ventilatory support

  3. Respiratory dysfunction

    SOFA respiratory component >1

    Measured: 28 days after initiation of ventilatory support

  4. Renal dysfunction

    SOFA respiratory component >1

    Measured: 28 days after initiation of ventilatory support

  5. Gastrointestinal dysfunction

    SOFA gastrointestinal component >1

    Measured: 28 days after initiation of ventilatory support

  6. Hematologic dysfunction

    SOFA hematologic component >1

    Measured: 28 days after initiation of ventilatory support

  7. ICU length of stay

    Duration from ICU admission to ICU discharge

    Measured: Up to 90 days following inclusion

  8. Hospital length of stay

    Duration from hospital admission to hospital discharge

    Measured: Up to 90 days following inclusion

  9. ICU mortality

    Status at ICU discharge either alive or deceased

    Measured: Up to 90 days following inclusion

  10. Hospital mortality

    Status at hospital discharge either alive or deceased

    Measured: Up to 90 days following inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start8 Jul 2022
  3. Primary completion31 Oct 2023
  4. Study completion30 Apr 2024

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382065
Sponsor's protocol ID
255/2565(IRB3)
Status last verified
May 2026
First submitted
16 May 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hebert PC, Blajchman MA, Cook DJ, Yetisir E, Wells G, Marshall J, Schweitzer I; Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. Do blood transfusions improve outcomes related to mechanical ventilation? Chest. 2001 Jun;119(6):1850-7. doi: 10.1378/chest.119.6.1850.

    PubMed 11399714

  • Hayden SJ, Albert TJ, Watkins TR, Swenson ER. Anemia in critical illness: insights into etiology, consequences, and management. Am J Respir Crit Care Med. 2012 May 15;185(10):1049-57. doi: 10.1164/rccm.201110-1915CI. Epub 2012 Jan 26.

    PubMed 22281832

  • Zilberberg MD, Stern LS, Wiederkehr DP, Doyle JJ, Shorr AF. Anemia, transfusions and hospital outcomes among critically ill patients on prolonged acute mechanical ventilation: a retrospective cohort study. Crit Care. 2008;12(2):R60. doi: 10.1186/cc6885. Epub 2008 Apr 28.

    PubMed 18442375

  • Penuelas O, Frutos-Vivar F, Fernandez C, Anzueto A, Epstein SK, Apezteguia C, Gonzalez M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.

    PubMed 21616997

  • Zilberberg MD, Luippold RS, Sulsky S, Shorr AF. Prolonged acute mechanical ventilation, hospital resource utilization, and mortality in the United States. Crit Care Med. 2008 Mar;36(3):724-30. doi: 10.1097/CCM.0B013E31816536F7.

    PubMed 18209667

  • Ghiani A, Sainis A, Sainis G, Neurohr C. Anemia and red blood cell transfusion practice in prolonged mechanically ventilated patients admitted to a specialized weaning center: an observational study. BMC Pulm Med. 2019 Dec 18;19(1):250. doi: 10.1186/s12890-019-1009-1.

    PubMed 31852456

  • Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.

    PubMed 30860564

  • Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.

    PubMed 9971864

  • Vlaar AP, Oczkowski S, de Bruin S, Wijnberge M, Antonelli M, Aubron C, Aries P, Duranteau J, Juffermans NP, Meier J, Murphy GJ, Abbasciano R, Muller M, Shah A, Perner A, Rygaard S, Walsh TS, Guyatt G, Dionne JC, Cecconi M. Transfusion strategies in non-bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine. Intensive Care Med. 2020 Apr;46(4):673-696. doi: 10.1007/s00134-019-05884-8. Epub 2020 Jan 7.

    PubMed 31912207

  • Lai YC, Ruan SY, Huang CT, Kuo PH, Yu CJ. Hemoglobin levels and weaning outcome of mechanical ventilation in difficult-to-wean patients: a retrospective cohort study. PLoS One. 2013 Aug 28;8(8):e73743. doi: 10.1371/journal.pone.0073743. eCollection 2013.

    PubMed 24015310

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia and Mechanical Ventilation, run by Mahidol University at 1 site in Thailand.

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 3 inclusion and 2 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 5 May 2026. 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 Thailand. 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?

Duration of mechanical ventilation (time frame: 28 days after initiation of ventilatory support). 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 NCT05382065, which also lists 10 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 5 May 2026.

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