No registrations found.
ID
Source
Brief title
Health condition
pediatric postoperative cardiac surgery patients, red blood cell transfusion, morbidity, nososcomial infection, MBL, venous saturation
pediatrische postoperatieve cardiochirurgische patienten, erytrocytentransfusie, morbiditeit, nosocomiale infecties, MBL, veneuze saturatie
Sponsors and support
IC centrum, LUMC, Prof. Dr. L.P.H.J. Aarts
Sanquin bloedbank zuid-west Nederland (Dr.L.M.G. van de Watering)
Sanquin bloedbank zuid-west Nederland, Dr.L.M.G. van de Watering
Intervention
Outcome measures
Primary outcome
Reduction in red blood cell transfusion and the morbidity related to the transfusion (expressed as ventilator days, length of PICU and hospital stay, nosocomial infections).
Secondary outcome
1. Can continuous venous saturation monitoring guide the transfusion policy?
2. How usefull are continuous oxygen saturation measurements?
3. What is the role of mannose binding lectin (MBL) and the development of nosocomial infections in transfused pediatric postoperative cardiac surgery patients.
Background summary
The practise of red blood cell transfusion in critically ill children is common practise. Treatment of anemia is the mean rationale for transfusing children after cardiac surgery. It is generally beleived that thay have a lower margin of safety for tolerance of low hemoglobin and that oxygen consumption improves when they are transfused. However this concept has never been proven. Additionally a well defined threshold value when to transfuse is unavailable. Recents studies in adults and children show increasing morbidity related to transfusion requirements. No adverse outcome was observed in a recent study in stable critically children when restricting the transfusion policy, accepting a lower threshold seems appropriate. Continuous oxygen saturation monitoring may be helpfull in the decision making of whether a red blood cell transfusion is required.
Study objective
Reduction in red blood cell transfusions is associated with a reduction morbidity, expressed as ventilator days, length of PICU and hospital stay, nosocomial infections.
Study design
The study starts at the operating room and patients are follwed for 28 days.
Continuous venous saturation measurement is maximum 72 hours, cerebral oxygen saturation (NIRS) 24 hours, all other monitoring is according to the standard protocol.
Bloodsamples are according to the standard protocol with two additional samples (after induction at te OR, after admittance on PICU).
Intervention
After inclusion the patients are randomised in two groups (restrictive and liberal transfusion policy). The transfusion triggerpoint for the restrice group is set at a hemoglobin of 5 mmol/L versus 6,8 in the liberal group.
In both groups patients are treated according to the standard protocol with all the minitoring they require postoperatively. Additionally continuous venous saturation is measured during maximum 72 hours, the storage time of the red blood cell is registered and mannose binding lectine is measured twice.
Postbus 9600
D.A.H. Gast-Bakker, de
Intensive Care Kinderen
kamer J4-31
Leiden 2300 RC
The Netherlands
d.h.Gast-Bakker_de@lumc.nl
Postbus 9600
D.A.H. Gast-Bakker, de
Intensive Care Kinderen
kamer J4-31
Leiden 2300 RC
The Netherlands
d.h.Gast-Bakker_de@lumc.nl
Inclusion criteria
Pediatric patients with a non-cyanotic congenital heart defect (>3 kg, >6 weeks and < 6 years) undergoing cardiac surgery.
Exclusion criteria
1. Neonates;
2. Underlying hematological disease (hemoglobinopathy);
3. Patients participating in another study that may interfere with this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1608 |
NTR-old | NTR1691 |
Other | METC LUMC : P07-168 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |