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Pharmacokinetics of ANP, a diuretic hormone, in newborns undergoing surgery for congenital heart defects? A pilot study.

Pharmacokinetics of ANP, a diuretic hormone, in neonates undergoing surgery for congenital heart defects. A pilot study. - Pharmacokinetics of ANP in newborns

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-003995-65-SE
Enrollment
Unknown
Registered
2015-09-24
Start date
2015-11-25
Completion date
Unknown
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute renal failure after heart surgery MedDRA version: 18.0 Level: PT Classification code 10038447 Term: Renal failure neonatal System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: HANP® Injection 1000 Product Name: HANP i.v. infusion Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: CARPERITIDE CAS Number: 89213-87-6

Sponsors

Västra Götalandsregionen, Sahlgrenska University Hospital /Queen Silvia children's hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children undergoing corrective heart surgery 2. Who develope acute renal failure 3. Will be treated with hANP 4. Age 1-12 months, 5. Dual-chamber physiology 6. Informed consent by parents/guardians Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the metabolism of hANP routinely given to newborn babies who develop acute renal failure associated with cardiac surgery.;Secondary Objective: Not applicable;Primary end point(s): Area under the curve (AUC), maximum concentration (Cmax), time to Cmax, clearance (CL), volume of distribution (Vd), half-life (t1 / 2) and mean residence time (MRT) and compartment modeling and physiological modeling.;Timepoint(s) of evaluation of this end point: T0 = Before starting treatment T1 = 1 hour after the start of treatment T2 = 2 hours after the start of treatment T4 = 4 hours after start T8 = 8 hours after start T16 = 16 hours after start T24 = 24 hours after start T32 = 32 hours after starting treatment T -1 = 1 hour before release T + 1 = 1 hour after release—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable—

Countries

Sweden

Contacts

Public ContactAnOpIVA

Sahlgrenska University Hospital /Queen Silvia children's hospital

albert.castellheim@gu.se+46(0)31343 45 28

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026