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Trial Outcomes & Findings for Angiotensin II Pathway and Postoperative Hypoxemia (NCT NCT05055570)

NCT ID: NCT05055570

Last Updated: 2024-01-26

Results Overview

Blood samples were taken within 24 hours after operation to detect the contents of ANG II in serum. Postoperative hypoxemia is defined by the oxygenation index (OI), which is the ratio of arterial partial pressure of oxygen to fraction inspired oxygen (PaO2 / FiO2), of less than or equal to 200 for two consecutive times within the first 24 h after operation

Recruitment status

COMPLETED

Target enrollment

88 participants

Primary outcome timeframe

Within 24 hours after surgery

Results posted on

2024-01-26

Participant Flow

Participant milestones

Participant milestones
Measure
Hypoxemia Group
oxygenation index (OI)≤200 No intervention: No intervention
Non-hypoxemia Group
oxygenation index (OI)\>200 No intervention: No intervention
Overall Study
STARTED
25
63
Overall Study
COMPLETED
25
63
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Angiotensin II Pathway and Postoperative Hypoxemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hypoxemia Group
n=25 Participants
oxygenation index (OI)≤200 No intervention: No intervention
Non-hypoxemia Group
n=63 Participants
oxygenation index (OI)\>200 No intervention: No intervention
Total
n=88 Participants
Total of all reporting groups
Age, Continuous
52.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
50.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
50.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
19 Participants
n=7 Participants
27 Participants
n=5 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
44 Participants
n=7 Participants
61 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
25 Participants
n=5 Participants
63 Participants
n=7 Participants
88 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Weight
83.9 Kg
STANDARD_DEVIATION 14.9 • n=5 Participants
74.4 Kg
STANDARD_DEVIATION 12.8 • n=7 Participants
77.1 Kg
STANDARD_DEVIATION 14.0 • n=5 Participants
Hight
169.7 cm
STANDARD_DEVIATION 7.6 • n=5 Participants
171.6 cm
STANDARD_DEVIATION 8.9 • n=7 Participants
171.1 cm
STANDARD_DEVIATION 8.6 • n=5 Participants
BMI
29.0 kg / m2
STANDARD_DEVIATION 3.7 • n=5 Participants
25.2 kg / m2
STANDARD_DEVIATION 3.4 • n=7 Participants
26.3 kg / m2
STANDARD_DEVIATION 3.9 • n=5 Participants

PRIMARY outcome

Timeframe: Within 24 hours after surgery

Blood samples were taken within 24 hours after operation to detect the contents of ANG II in serum. Postoperative hypoxemia is defined by the oxygenation index (OI), which is the ratio of arterial partial pressure of oxygen to fraction inspired oxygen (PaO2 / FiO2), of less than or equal to 200 for two consecutive times within the first 24 h after operation

Outcome measures

Outcome measures
Measure
Hypoxemia Group
n=25 Participants
oxygenation index （PaO2 / FiO2）≤200
Non-hypoxemia Group
n=63 Participants
oxygenation index （PaO2 / FiO2）\>200
The Difference Concentrations of ANG II in Serum Between Patients With and Without Postoperative Hypoxemia.
100 pg / mL
Interval 73.9 to 117.6
78.5 pg / mL
Interval 60.9 to 92.1

SECONDARY outcome

Timeframe: up to 60 days

Basic characteristics, intraoperative details, biochemical parameters and outcome results were obtained, and blood was collected within 24 hours after surgery for the measurement of ANG II, sACE2 and mir-145 concentrations. Univariate analysis was first performed to identify the potential risk factors for postoperative hypoxemia. Multivariate logistic regression analysis was performed for factors with P \< 0.05 or that were considered clinically important.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 days

Duration of Stay in the intensive care unit after surgery

Outcome measures

Outcome data not reported

Adverse Events

Hypoxemia Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Non-hypoxemia Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jun Ma

Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University

Phone: 13370103671

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place