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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05382065
Other study ID # 255/2565(IRB3)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 8, 2022
Est. completion date December 2023

Study information

Verified date August 2022
Source Mahidol University
Contact Annop Piriyapatsom, MD
Phone +6624197990
Email annop.pir@mahidol.ac.th
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 intensive care unit who required ventilatory support >96 hr.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Thailand Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok Noi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

Hébert 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. — View Citation

Hébert 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. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056. — View Citation

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. — View Citation

Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Folléa 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. — View Citation

Peñuelas O, Frutos-Vivar F, Fernández C, Anzueto A, Epstein SK, Apezteguía C, González 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of mechanical ventilation Days patients received mechanical ventilation 28 days after initiation of ventilatory support
Secondary Duration of anemia Days patients had hemoglobin level <8 g/dl while they were on ventilatory support 28 days after initiation of ventilatory support
Secondary Cardiovascular dysfunction SOFA cardiovascular component equal to 1, 3, or 4 28 days after initiation of ventilatory support
Secondary Respiratory dysfunction SOFA respiratory component >1 28 days after initiation of ventilatory support
Secondary Renal dysfunction SOFA respiratory component >1 28 days after initiation of ventilatory support
Secondary Gastrointestinal dysfunction SOFA gastrointestinal component >1 28 days after initiation of ventilatory support
Secondary Hematologic dysfunction SOFA hematologic component >1 28 days after initiation of ventilatory support
Secondary ICU length of stay Duration from ICU admission to ICU discharge Up to 90 days following inclusion
Secondary Hospital length of stay Duration from hospital admission to hospital discharge Up to 90 days following inclusion
Secondary ICU mortality Status at ICU discharge either alive or deceased Up to 90 days following inclusion
Secondary Hospital mortality Status at hospital discharge either alive or deceased Up to 90 days following inclusion
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