Anemia and Duration of Mechanical Ventilation

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382065
• Other study ID #: 255/2565(IRB3)
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anemia
• Critical Illness
• Critically Ill
• Intensive Care Unit
• Mechanical Ventilation
• Morality
• Organ Dysfunction Syndrome

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