Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.
The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colloid | Active Comparator | 5% albumin for volume resuscitation |
|
| Crystalloid | Placebo Comparator | Saline for volume resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% albumin | Other | 5% albumin in 10cc/kg aliquots for postoperative volume resuscitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure | Throughout the post operative period |
| Measure | Description | Time Frame |
|---|---|---|
| lactate clearance | Throughout the post operative period | |
| inotropic requirements | throughout the post operative period | |
| establishment of adequate urine output |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary B Taylor, M.D., MSCI | Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Monroe Carell, Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232-9075 | United States |
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000418 | Albumins |
| D003102 | Colloids |
| D000077324 | Crystalloid Solutions |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| crystalloid | Other | saline in 10cc/kg aliquots for postoperative volume resuscitation |
|
|
| Throughout the post operative period |
| post-operative occurrence of edema (peripheral and pulmonary) | Througout the post operative period |
| monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay | Throughout the ICU stay |
| D004364 |
| Pharmaceutical Preparations |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |