The Prophylactic Effect of Levosimendan in Reducting Acute Kidney Injury Postoperatively in Pediatric Patients Undergoing Corrective Heart Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- S-creatinine
Study Overview
Brief Summary
The aim of the study is to assess the ability of Levosimendan to reduce the postoperative acute kidney injury in pediatric patients undergoing surgery for congenital heart disease (CHDs).
Detailed Description
Young children, between the age of 1 to 12 months, with congenital heart disease in need of elective heart surgery will be included in this study.
The trial will contain two study groups, 35 patients in each. One group will receive Levosimendan and the second group will receive Milrinone as a heart muscle-strengthening agent during and after the operation. Milrinone is currently used as the drug of choice in many pediatric cardiac surgery centers. It remains to see if Levosimendan can exert a kidney protecting function in addition to its heart muscle-strengthening properties.
The primary objective of this study is to investigate the preventive effect of Levosimendan on postoperative acute kidney injury in pediatric patients undergoing surgery for their CHDs. Creatinine levels postoperatively will be the primary endpoint. Creatinine, the common marker of kidney injury, will be measured daily.
The treatment with Levosimendan or Milrinone will be started during the operation (after initiation of cardiopulmonary bypass) and will last 24 hours. Blood samples will be obtained at six occasions perioperatively. Patients will be followed 4 days after termination of treatment (totally 5 days).
The duration of study will be 30 days (24 hours treatment + 4 days follow up + 30-days-mortality registration).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 1 Month to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures
- •Female and male children between 1 and 12 months of age
- •Non-restrictive VSD (corrective surgery)
- •Complete AVSD (biventricular repair)
- •Tetralogy of Fallot
Exclusion Criteria
- •Unbalanced AtrioVentricular Septal Defect or AVSD with cyanosis
- •Age less than one month and more than one year
- •Acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
- •Mild, moderate, or severe kidney dysfunction and known anatomical anomalies of kidneys
- •Liver impairment or disease
- •Ongoing infection
- •Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day. Contrast agents whithin 24 hours before operation.
- •Use of inhibitors of membrane transport proteins (cimetidine, cetirizine, trimethoprim, probenecid, rifampin and gemfibrosil).
- •Allergy to Levosimendan or substance included in the preparation or previous use of Levosimendan.
- •Severe arrhythmias needing pace-maker treatment prior to the operation
- •Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation.
- •Preoperative need for mechanical ventilation and/or inotropic agents.
- •Re-operation (open heart surgery). Earlier surgical closure of the arterial duct does not count as an exclusion criteria.
- •Prematurity: Gestational age < 30 weeks, irrespective of postpartum age. Gestational age 30-34 weeks if patient is included at postpartum age under 3 months.
Arms & Interventions
Levosimendan
In this arm the patients will receive Levosimendan as an inotrope agent. Concentration: 0.05 mg/mL Infusion rate: 0.12 mL / kg / hr = Dose delivered 0.1 μg / kg / min --- Bolus dose: 1.44 ml / kg / hr in ten minutes (a maximum volume 0.24 ml / kg) = 12 μg/kg
Intervention: Levosimendan (Drug)
Milrinone
In this arm the patients will receive Milrinone as an inotrope agent. Concentration: 0.2 mg/mL Infusion rate: 0.12 mL / kg / hr = Dose delivered 0.4 μg / kg / min --- Bolus dose: 1.44 ml / kg / hr in ten minutes (a maximum volume 0.24 ml / kg) = 48 μg / kg
Intervention: Milrinone (Drug)
Outcomes
Primary Outcomes
S-creatinine
Time Frame: One day after cardiac surgery
The primary outcome variable was the absolute value of serum creatinine data on postoperative day 1.
Secondary Outcomes
- 30 Days Mortality(30 days)
- Acute Kidney Injury (AKI)(Two days (second postoperative day))
Investigators
Albert Castellheim
Associate professor
Göteborg University