The primary goal of this study is to compare the routinely use infant COP protocol (old protocol) with new approach to the COP regulation (new protocol) with regard to perioperative fluid shift, lung function and allogeneic transfusion requirements.…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be weighted immediately preoperatively and postoperatively before
leaving the OR. At the same moments extravascular lung water (EVLWI) will be
measured with the PiCCO monitor.
Ratio between the fraction of inspired oxygen and the partial pressure of
oxygen in arterial blood (PaO2/FiO2) and positive end - expiratory pressure
(PEEP) will be recorded preoperatively, before leaving the OR, at 4 and 24 hour
postoperatively. Hemoglobin concentration (Hb), Hematocrit (Hct) and platelet
count (Pl), COP and serum albumin concentration (Alb) will be measured
preoperatively and before leaving the OR, during the CPB at the 5 minutes on
bypass and at the end. During the postoperative period, measurements will be
performed at 4 and 24 hours in the ICU.
Secondary outcome
CPB data such as; CPB time, aortic cross-clamp time, lowest nasopharyngeal
temperature, and surgery data, length of stay at the ICU and duration of
mechanical ventilation will be collected during the study period. Type and
volume of all crystalloid, colloid and blood components administrated in the
OR, including transfusion during the CPB, and administrated during the stay at
the ICU will be noted.
Intraoperative and postoperative blood loss and urine output will be recorded,
together with intraoperative and postoperative use of diuretics.
Background summary
Cardiopulmonary bypass (CPB) utilized in cardiac surgery remains a
nonphysiological procedure that may cause severe hemodilution and an acute
inflammatory body response. Therefore, capillary leakage syndrome (CLS), a
condition of episodic capillary hyperpermaebility to macromolecules, that
shifts fluid and plasma proteins from the intravascular to the interstitial
space, may occur. Variety of colloidal and crystalloid solutions used in the
prime of a CPB circuit and during CPB very often decrease level of serum COP.
Lower plasma COP favours a fluid shift from the intravascular space into
interstitial space, with formation of organs edema.
Study objective
The primary goal of this study is to compare the routinely use infant COP
protocol (old protocol) with new approach to the COP regulation (new protocol)
with regard to perioperative fluid shift, lung function and allogeneic
transfusion requirements.
Diminishing of fluid shift into the extravascular space will result in higher
levels of hematocrit and platelet count in the postoperative period. Therefore,
transfusion of allogeneic blood products will be reduced. The impairment of
pulmonary function following CPB will be attenuated and the recovery and the
length of ICU stay will be shorter.
Study design
Prospective randomized trial with two groups of patients with body weight
under 10 kg . For both study groups, CPB prime (300 ml) will contain homologous
red blood cells concentrate (RBCs), fresh-frozen plasma (FFP) and Gelofusine
(B.Braun, Melsungen, Germany). The amount of RBCs added to the prime will be
calculated to achieve a hematocrit of 0.28 L/L during CPB and ratio between
volume of FFP and Gelofusine will be 1:1.
In the old protocol group a 0.5 g/kg BW of human albumin (20% solution) will be
added into the prime, in accordance with existing infant CPB protocol. In the
new protocol group, volume of human albumin (20% solution) will be calculated
to achieve 5% albumin concentration in the CPB prime.
Regulation of COP during the CPB will be achieved by addition of human albumin
20% solution. In the old protocol group during the CPB target value of COP will
be not lower than 15 mmHg and in the new protocol group COP not lower than 18
mmHg.
Intervention
In the old protocol group a 0.5 g/kg BW of human albumin (20% solution) will be
added into the prime, in accordance with existing infant CPB protocol. In the
new protocol group, volume of human albumin (20% solution) will be calculated
to achieve 5% albumin concentration in the CPB prime. Regulation of COP during
the CPB will be achieved by addition of human albumin 20% solution. In the old
protocol group during the CPB target value of COP will be not lower than 15
mmHg and in the new protocol group COP not lower than 18 mmHg.
Surgical and anaesthesia procedures will be not altered for the purpose of this
study.
Study burden and risks
NA
's Gravendijkwal 230 / Postbus 2040
3015 CE ROTTERDAM / 3000 CA ROTTERDAM
NL
's Gravendijkwal 230 / Postbus 2040
3015 CE ROTTERDAM / 3000 CA ROTTERDAM
NL
Listed location countries
Age
Inclusion criteria
Infants with body weight lower or equal to 10 kg, elective operation
Exclusion criteria
Infants with body weight of more than 10 kg.
Reoperations
Urgent operations
Premature
Infants with kidney and or liver insufficiency
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-000069-41-NL |
| CCMO | NL21403.078.08 |