Regulation of COP during CPB in infants

Regulation of Colloid Osmotic Pressure during Cardio Pulmonary Bypass in infants: a prospective randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27927

Enrollment

120

Registered

2008-10-07

Start date

2008-04-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

COP CPB infants prime regulation heartsurgery

Interventions

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 albu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants with body weight < 10kg 2. Elective surgery 3. First time surgery

Exclusion criteria

Exclusion criteria: 1. Infants with body weight >= 10 kg 2. Prematurity 3. Reoperation 4. Non elective surgery 5. Hepatic and or renal insufficiency 6. Procedures that require deep hypothermic circulation arest

Design outcomes

Primary

Measure	Time frame
Study primary endpoints variables are: - Intravascular COP - Plasma albumin concentration - Body weight gain measured at the end of the operation, before leaving the operation room. We expect 50 % increase of COP and albumin levels by implementation of the new protocol. The body weight gain is expected to be diminished by 75%. Additionally, we would like to study the relationship between the COP value at the end of the operation and postoperative transfusion requirements and blood loss, gas exchange, duration of mechanical ventilation and length of stay in the intensive care unit (ICU).	—

Measure

Time frame

Study primary endpoints variables are: - Intravascular COP - Plasma albumin concentration - Body weight gain measured at the end of the operation, before leaving the operation room. We expect 50 % increase of COP and albumin levels by implementation of the new protocol. The body weight gain is expected to be diminished by 75%. Additionally, we would like to study the relationship between the COP value at the end of the operation and postoperative transfusion requirements and blood loss, gas exchange, duration of mechanical ventilation and length of stay in the intensive care unit (ICU).

—

Secondary

Measure	Time frame
Study secondary endpoints variables are: - Postoperative blood loss - Amount of transfused RBCs, FFP and GPO - PaO2/FiO2 gas exchange factor measured at the end of operation - Duration of postoperative mechanical ventilation and length of stay in the intensive care unit (ICU). The difference of 50 % is expected between the groups. The statistically significant (p=0,05) correlation between the COP value at the end of the operation and secondary variables will be established.	—

Measure

Time frame

Study secondary endpoints variables are: - Postoperative blood loss - Amount of transfused RBCs, FFP and GPO - PaO2/FiO2 gas exchange factor measured at the end of operation - Duration of postoperative mechanical ventilation and length of stay in the intensive care unit (ICU). The difference of 50 % is expected between the groups. The statistically significant (p=0,05) correlation between the COP value at the end of the operation and secondary variables will be established.

—

Contacts

Public ContactH.D. Golab

Erasmus MC Department of Cardio-thoracic Surgery BD-467 P.O. Box 2040

h.golab-schwarz@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)