Clinical Trials Logo
  1. Home
  2. Hypothermia
  3. NCT03129620

Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy

Hypothermia Clinical Trial

Official title:
Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy Undergoing Controlled Hypothermia

Clinical Trial Summary

Controlled Hypothermia has become the standard of care for neonates with moderate to severe HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may not be responsible for the etiology of HIE. Currently, medication dosage regimens are not altered in the setting of CH. A better understanding of the effects of our interventions on this unique population may help us tailor our therapy to the specific circumstances of the patient

Clinical Trial Description

Hypoxic-ischemic encephalopathy (HIE) affects approximately 1 to 2 per 1000 live births and remains a cause of significant morbidity and mortality in the neonatal period. In response to an anoxic insult, perfusion to vital organs is preserved; however, when this injury is profound concomitant injury to nonvital organs is observed. Controlled hypothermia (CH) has been accepted as a neuroprotective therapeutic modality for neonates with moderate to severe HIE because of its role in attenuating secondary brain injury. Neonates exhibit varying degrees of multiorgan dysfunction after a hypoxic-ischemic insult, although the added beneficial and potential adverse effects that CH has in these babies have not been completely delineated or understood.

CH has been shown to alter normal physiologic functioning of several organ systems. Specific physiologic changes as a consequence of CH have been demonstrated in both animal and human models. The observed reduction in cardiac output and reflexive increase in systemic vascular resistance in response to CH alter renal perfusion and subsequently reduce glomerular filtration . Drugs that are renally cleared may develop a prolonged half-life in this setting. Finally, drug metabolism may further be affected by altered hepatic blood flow and temperature-dependent effects on hepatic enzyme activity . Collectively, the potential effects of CH on drug metabolism and clearance are significant warranting further investigation. The investigator aims to evaluate the combined effects of hypoxia and hypothermia on ampicillin clearance and excretion ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03129620
Study type Observational
Source Drexel University
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date April 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Not yet recruiting NCT05306392 - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation N/A
Completed NCT02685176 - Head and Torso Rewarming Using a Human Model for Severe Hypothermia N/A
Withdrawn NCT02812069 - WarmSmart Warming Protocol N/A
Completed NCT02586974 - Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response N/A
Completed NCT02121574 - Accuracy of Zero-flux and Ingestible Thermometers N/A
Completed NCT02177903 - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes N/A
Not yet recruiting NCT02211703 - National Epidemiologic Survey on the Incidence of Perioperative Hypothermia N/A
Completed NCT02742818 - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models N/A
Recruiting NCT01866384 - Targeted Temperature Management After Intracerebral Hemorrhage Phase 2
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01722955 - Pre-warmed Intravenous Fluids and Monitored Anesthesia Care N/A
Completed NCT01793337 - Core Body Temperature Measurement During Hot and Cold Environmental Exposure N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Terminated NCT01018576 - Delayed Cord Clamping in Premature Infants N/A
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Completed NCT00904228 - Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room N/A
Completed NCT00334360 - Dexmed/Buspirone Synergism on Shivering Phase 4
Not yet recruiting NCT06283771 - The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering N/A
Completed NCT04399902 - Study to Actively Warm Trauma Patients N/A