Anemia and Duration of Mechanical Ventilation

• Conditions: Anemia; Critically Ill; Intensive Care Unit; Organ Dysfunction Syndrome; Mechanical Ventilation; Morality

• Registration Number: NCT05382065
• Lead Sponsor: Mahidol University

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.

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.

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2022-07-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	28 days after initiation of ventilatory support	Days patients received mechanical ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand