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Natriuretic Peptide Concentrations of B-type (BNP) During Anesthesia in Patients Previously Sensitized to Anthracyclines (PEP-NAT-B)

I

Institut Bergonié

Status

Completed

Conditions

Breast Cancer

Treatments

Other: Dosage of B-type natriuretic peptide (NT-proBNP)

Study type

Interventional

Funder types

Other

Identifiers

NCT01754597
IB2009-39

Details and patient eligibility

About

The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.

Full description

The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. In fact, it is one of the most sensitive markers of impaired myocardial function, and an increase in interest rates may precede any other biological changes. In a patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP concentration may persist for some months after exposure, and that, whatever the doses received. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.

Enrollment

54 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women over 18 years with effective contraceptive method (if applicable)
  • NT-proBNP <125 pg / ml
  • ASA 1 or 2,
  • Breast cancer histologically proven
  • Mastectomy or lumpectomy
  • Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy with anthracyclines,
  • Patients who received the briefing and signed the informed consent
  • Patients affiliated to a social security system.

Exclusion criteria

  • Patients for whom the maintenance of general anesthesia does not use halogenated.
  • Renal impairment: Creatinine clearance <60 ml / min,
  • Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship.
  • Presence of a cardiopathy
  • Pregnant Women

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Participants not previously treated with anthracyclines
Other group
Description:
No anthracycline treatment in the 6 months prior to inclusion.
Treatment:
Other: Dosage of B-type natriuretic peptide (NT-proBNP)
Participants previously treated with anthracyclines
Other group
Treatment:
Other: Dosage of B-type natriuretic peptide (NT-proBNP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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