Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns (CORTISoL)
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|ClinicalTrials.gov Identifier: NCT02700828|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : April 18, 2018
This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed.
The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency that may contribute to hypotension and lower efficacy of inotropic therapy in this patient population. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation besides conventional inotropic therapy in a placebo-controlled fashion.
|Condition or disease||Intervention/treatment||Phase|
|Hypoxic-Ischemic Encephalopathy Asphyxia||Drug: Hydrocortisone Drug: Placebo||Phase 2 Phase 3|
The researchers hypothesized that asphyxiated neonates undergoing therapeutic hypothermia develop relative adrenal insufficiency that contributes to "late onset" (>24 hours after birth) hypotension resistant to optimized pharmacological support.
Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation.
- To study initial serum cortisol levels in asphyxiated newborns undergoing therapeutic hypothermia with late onset hypotension.
- To demonstrate that in asphyxiated newborns undergoing therapeutic hypothermia and presenting with systemic hypotension resistant to optimized pharmacological support, low dose hydrocortisone supplementation restores normal blood pressure when compared to placebo.
- Prospective, randomized, double-blind, single center, cohort study
- 1st Department of Paediatrics, NICU, Semmelweis University, Hungary
- Starting date: 02/14/2016
- Patient number: 16 vs 16 (hydrocortisone vs placebo - based on previous observational study results)
- Intervention (hydrocortisone vs placebo) applied only during therapeutic hypothermia (max. 72 hours)
- Neurodevelopmental follow-up visit: Bayley II/III scale to evaluate the effect of hydrocortisone treatment on the neurological development at the age between 18 and 22 months.
Drugs for hypotension, the hydrocortisone protocol:
- Fluid replacement (volume bolus: 10-20 ml/kg isotonic saline, over 15 minutes, according to the clinician's decision)
- In case of persisting hypotension: serum sample is collected for cortisol measurement.
Randomization, irrespective of actual cortisol level. As the study is blinded, enrollment in the clinical trial will/shall not influence the clinical decision making about further interventions. A dedicated study assistant will be available to prepare the drug / placebo for the newborns.
- Inotropic therapy (dopamine, following the standard titration protocol)
- AND (at start of dopamine) hydrocortisone: 4 * 0,5 mg/kg /24 hours (in every 6 hours) or placebo administration (the corresponding amount of isotonic saline)
- After randomization, intervention is continued until the end of hypothermia treatment (max. 72 hours), with the same dose. Inotropic therapy will be titrated as needed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prospective, Randomized, Double-blind, Cohort Study of Hydrocortisone vs Placebo in Systemic Low Blood Pressure During Hypothermia Treatment in Asphyxiated Newborns|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||February 2020|
Active Comparator: Hydrocortisone
Hydrocortisone is the pharmaceutical term for cortisol, the principal glucocorticoid secreted by the adrenal gland
4 * 0,5 mg/kg /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
Other Name: Solu-Cortef
Placebo Comparator: Placebo
Isotonic sodium chloride is an aqueous solution of 0.9 percent sodium chloride which is isotonic with the blood and tissue fluid
4 * 2 ml isotonic sodium chloride solution /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
Other Name: Isotonic saline
- Compare mean arterial blood pressure (MAP) change in the patients receiving hydrocortisone vs placebo [ Time Frame: 2 hours ]Circulatory stability as measured by an increased MAP (5 mmHg) within two hours after drug administration
- Frequency of initially low serum cortisol in hypotensive asphyxiated newborns undergoing therapeutic hypothermia [ Time Frame: before hydrocortisone administration within max. 72 hours ]Initially low serum cortisol - proven relative adrenal insufficiency
- Length of dopamine treatment in the patients receiving hydrocortisone vs placebo [ Time Frame: 72 hours ]Compare dopamine treatment's length (in hours) in the patients receiving hydrocortisone vs placebo
- Cumulative dopamine dose in the patients receiving hydrocortisone vs placebo [ Time Frame: 72 hours ]Compare cumulative dopamine dose (mcg/kg) in the patients receiving hydrocortisone vs placebo
- Change in hourly diuresis in the patients receiving hydrocortisone vs placebo [ Time Frame: 72 hours ]Measure and compare the hourly diuresis (ml/kg/hour) in the patients receiving hydrocortisone vs placebo
- Change in the echocardiography parameters (fractional shortening and cardiac output) in the patients receiving hydrocortisone vs placebo [ Time Frame: 72 hours ]Fractional shortening (FS%) and cardiac output (CO in ml/kg/min) measurements before and after hydrocortisone or placebo, during the first 72 hours (during hypothermia treatment)
- Long term neurodevelopmental outcome in the patients receiving hydrocortisone vs placebo [ Time Frame: 18-22 month ]Performance on motor and mental scales of Bayley II/III scales of infant development
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700828
|Semmelweis University, 1st Department of Paediatrics|
|Budapest, Pest, Hungary, 1083|
|Study Director:||Miklós Szabó, MD, PhD||Semmelweis University, 1st Department of Paediatrics|