Intraveneus Volume replacement with colloids

Comparison of the volume needed to replace intravenous fluids with Hydroxyethyl Starch 130 / 0.4 solution with 5% human albumin solution in patients under 2 years of age candidate for open heart surgery.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016050220793N4

Enrollment

Registered

2017-10-02

Start date

2015-08-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Congenital heart disease. Congenital malformations of cardiac chambers and connections

Interventions

Intervention 1: In the first group, a solution of 6% 130 / 0.4 Hydroxyethyl starch will be used.Ringer's solution will be used to substitute volume loss before the CPB. Patient will be excluded from t

Treatment - Drugs

In the first group, a solution of 6% 130 / 0.4 Hydroxyethyl starch will be used.Ringer's solution will be used to substitute volume loss before the CPB. Patient will be excluded from the study if bloo

In the second group, a solution of 10% Human Albumin will be used.Ringer's solution will be used to substitute volume loss before the CPB. Patient will be excluded from the study if blood transfusion

Eligibility

Sex/Gender

All

Age

No minimum to 2 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Age under two years; ASA class I-III. Exclusion criteria: Co-existing liver or coagulation disorder; previous cardiac surgery; impaired consciousness before surgery, anemia; cerebral hemorrhage; hyper or hyponatremia; Severe cardiac or respiratory failure; platelet count less than 100,000; kidney disease with oliguria or anuria.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The volume required to replace intravenous fluids by Hydroxyethyl Starch 130 / 0.4. Timepoint: End point of the study. Method of measurement: Millilitres, referring to the case.;The volume required to replace intravenous fluids by 10% Albumin. Timepoint: End point of the study. Method of measurement: Millilitres, referring to the case.	—

Secondary

Measure	Time frame
Renal Artery oxygen saturation. Timepoint: During the intervention. Method of measurement: Renal oximetry.;Cerebral oximetry. Timepoint: During the intervention. Method of measurement: Cerebral oximetry.;Mean Arterial Pressure. Timepoint: During the intervention. Method of measurement: Invasive blood pressure.;Urine output. Timepoint: During the intervention. Method of measurement: ml/kg/hr.;Blood loss. Timepoint: During the intervention and 24 hours after. Method of measurement: milliliters.;Arterial blood oxygen saturation. Timepoint: During the intervention. Method of measurement: Percent pulseoximetry.;Arterial blood lactate level. Timepoint: During the intervention. Method of measurement: meq/ml Blood gas analysis system.;PH lower than 7.35. Timepoint: During the intervention. Method of measurement: Blood gas analysis system.;Central venous pressure. Timepoint: During the intervention. Method of measurement: Invasive blood pressure.;Inotrope needed to keep normal blood pressure. Timepoint: During the intervention. Method of measurement: Reffered to the case.;Platelet count. Timepoint: During the intervention and 24 hours after. Method of measurement: Sysmex system.;Tranfused platelet units. Timepoint: During the intervention and 24 hours after. Method of measurement: Reffered to the case.	—

Measure

Time frame

Renal Artery oxygen saturation. Timepoint: During the intervention. Method of measurement: Renal oximetry.;Cerebral oximetry. Timepoint: During the intervention. Method of measurement: Cerebral oximetry.;Mean Arterial Pressure. Timepoint: During the intervention. Method of measurement: Invasive blood pressure.;Urine output. Timepoint: During the intervention. Method of measurement: ml/kg/hr.;Blood loss. Timepoint: During the intervention and 24 hours after. Method of measurement: milliliters.;Arterial blood oxygen saturation. Timepoint: During the intervention. Method of measurement: Percent pulseoximetry.;Arterial blood lactate level. Timepoint: During the intervention. Method of measurement: meq/ml Blood gas analysis system.;PH lower than 7.35. Timepoint: During the intervention. Method of measurement: Blood gas analysis system.;Central venous pressure. Timepoint: During the intervention. Method of measurement: Invasive blood pressure.;Inotrope needed to keep normal blood pressure. Timepoint: During the intervention. Method of measurement: Reffered to the case.;Platelet count. Timepoint: During the intervention and 24 hours after. Method of measurement: Sysmex system.;Tranfused platelet units. Timepoint: During the intervention and 24 hours after. Method of measurement: Reffered to the case.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehrang Nooralishahi

TUMS

b-nooralishahi@sina.tums.ac.ir+98 21 6691 1030

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026