Trial Outcomes & Findings for Natriuretic Peptide Concentrations of B-type (BNP) During Anesthesia in Patients Previously Sensitized to Anthracyclines (NCT NCT01754597)
NCT ID: NCT01754597
Last Updated: 2025-10-01
Results Overview
Mean concentration of NT-proBNP measured before surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Before breast surgery
Results posted on
2025-10-01
Participant Flow
Participant milestones
| Measure |
Participants Not Previously Treated With Anthracyclines
No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Participants Previously Treated With Anthracyclines
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
25
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Participants Not Previously Treated With Anthracyclines
No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Participants Previously Treated With Anthracyclines
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
|---|---|---|
|
Overall Study
Dosage of NT-proBNP not performed
|
6
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants Not Previously Treated With Anthracyclines
n=23 Participants
No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Participants Previously Treated With Anthracyclines
n=20 Participants
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 8.4 • n=23 Participants
|
49.3 years
STANDARD_DEVIATION 8.5 • n=20 Participants
|
52 years
STANDARD_DEVIATION 8 • n=43 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=23 Participants
|
20 Participants
n=20 Participants
|
43 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=23 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
23 participants
n=23 Participants
|
20 participants
n=20 Participants
|
43 participants
n=43 Participants
|
PRIMARY outcome
Timeframe: Before breast surgeryMean concentration of NT-proBNP measured before surgery.
Outcome measures
| Measure |
Participants Not Previously Treated With Anthracyclines
n=23 Participants
No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Participants Previously Treated With Anthracyclines
n=20 Participants
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
|---|---|---|
|
Pre-operative Concentration of NT-proBNP
|
38.9 pg/ml
Standard Deviation 27.0
|
32.2 pg/ml
Standard Deviation 18.4
|
PRIMARY outcome
Timeframe: At the end of breast surgeryPopulation: Participants with dosage available
Mean concentration of NT-proBNP measured at the end of intervention
Outcome measures
| Measure |
Participants Not Previously Treated With Anthracyclines
n=22 Participants
No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Participants Previously Treated With Anthracyclines
n=20 Participants
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
|---|---|---|
|
Concentration of NT-proBNP at the End of Intervention
|
42.2 pg/ml
Standard Error 28.0
|
34.6 pg/ml
Standard Error 20.0
|
PRIMARY outcome
Timeframe: 24 hours after breast surgeryPopulation: Participants with NT-proBNP dosage available
Mean concentration of NT-proBNP measured 24 hours after breast surgery
Outcome measures
| Measure |
Participants Not Previously Treated With Anthracyclines
n=23 Participants
No anthracycline treatment in the 6 months prior to inclusion.
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
Participants Previously Treated With Anthracyclines
n=20 Participants
Dosage of B-type natriuretic peptide (NT-proBNP): NT-proBNP concentration assessed at the following time points :
* T0: before induction of general anesthesia, NT-proBNP measurement
* T1: 30 minutes after induction of general anesthesia
* T2: at the end of the procedure
* T3: in the postoperative period, 6 hours after the end of the procedure
* T4: in the postoperative period, 24 hours after the end of the procedure
|
|---|---|---|
|
Post-operative Concentration of NT-proBNP
|
107.6 pg/ml
Standard Deviation 79.1
|
75.9 pg/ml
Standard Deviation 61.1
|
Adverse Events
Participants Not Previously Treated With Anthracyclines
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Previously Treated With Anthracyclines
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
Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR
Phone: +33 5 56 33 33 33
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place