Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00569855
Other study ID # 06611
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2007
Last updated February 3, 2011
Start date February 2001
Est. completion date August 2010

Study information

Verified date February 2011
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass machine to deliver blood and oxygen to all of the organs and tissues.


Recruitment information / eligibility

Status Completed
Enrollment 785
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- 0-18 years of age

- weight of less than or equal to 20 kilograms

Exclusion Criteria:

- Parental refusal to give informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Phenoxybenzamine
0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU

Locations

Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively Number of subjects who required Norepinephrine >0.1mcq/kg/min 72 hours postoperatively Yes
See also
  Status Clinical Trial Phase
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Completed NCT02518087 - Increased Adsorption Membranes During Cardiopulmonary Bypass N/A
Recruiting NCT01231776 - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass N/A
Completed NCT00747331 - Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass Phase 4
Terminated NCT00176657 - The Use of HEMOBAG to Salvage Blood After Cardiac Surgery Phase 2
Completed NCT00161733 - Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery Phase 3
Completed NCT05537168 - Bayesian Networks in Pediatric Cardiac Surgery
Completed NCT05525195 - Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
Completed NCT04238806 - Desflurane,Brain Natriuretic Peptide and Cardiac Surgery N/A
Completed NCT00981474 - Cerebral Autoregulation Monitoring During Cardiac Surgery N/A
Recruiting NCT05588011 - Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass N/A
Completed NCT02566733 - Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass Phase 4
Terminated NCT00385450 - Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor Phase 1
Completed NCT00246740 - Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting Phase 2
Not yet recruiting NCT05075265 - Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
Recruiting NCT04296071 - Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Active, not recruiting NCT04133740 - Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study Phase 4
Completed NCT05033236 - Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)