Anemia Clinical Trial
Official title:
The Correlation Between Period of Anemia and Duration of Mechanical Ventilation in Patients Admitted to the Surgical Intensive Care Unit
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok Noi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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
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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