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

Conditions: Acute renal failure after heart surgery
MedDRA version: 18.0Level: PTClassification code 10038447Term: Renal failure neonatalSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2015-003995-65-SE

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Not applicable

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>T1 = 1 hour after the start of treatment<br>T2 = 2 hours after the start of treatment<br>T4 = 4 hours after start<br>T8 = 8 hours after start<br>T16 = 16 hours after start<br>T24 = 24 hours after start<br>T32 = 32 hours after starting treatment<br>T -1 = 1 hour before release<br>T + 1 = 1 hour after release

Secondary Outcome Measures