NCT05382065

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

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

May 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 16, 2022

Last Update Submit

May 2, 2026

Conditions

AnemiaMechanical VentilationCritically IllIntensive Care UnitMoralityOrgan Dysfunction Syndrome

Keywords

Duration of mechanical ventilationDuration of anemiaIntensive care unitMortalityOrgan dysfunction

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical ventilation

    Days patients received mechanical ventilation

    28 days after initiation of ventilatory support

Secondary Outcomes (10)

  • Duration of anemia

    28 days after initiation of ventilatory support

  • Cardiovascular dysfunction

    28 days after initiation of ventilatory support

  • Respiratory dysfunction

    28 days after initiation of ventilatory support

  • Renal dysfunction

    28 days after initiation of ventilatory support

  • Gastrointestinal dysfunction

    28 days after initiation of ventilatory support

  • +5 more secondary outcomes

Eligibility Criteria

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

Adult patients admitted to the surgical intensive care unit and required ventilatory support with invasive mechanical ventilation for more than 96 hours

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (10)

  • 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.

    PMID: 11399714BACKGROUND

  • 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.

    PMID: 22281832BACKGROUND

  • 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.

    PMID: 18442375BACKGROUND

  • 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.

    PMID: 21616997BACKGROUND

  • 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.

    PMID: 18209667BACKGROUND

  • 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.

    PMID: 31852456BACKGROUND

  • 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.

    PMID: 30860564BACKGROUND

  • 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.

    PMID: 9971864BACKGROUND

  • 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.

    PMID: 31912207BACKGROUND

  • 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.

    PMID: 24015310BACKGROUND

MeSH Terms

Conditions

AnemiaCritical Illness

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annop Piriyapatsom, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 19, 2022

Study Start

July 8, 2022

Primary Completion

October 31, 2023

Study Completion

April 30, 2024

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)