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Electrophysiological analysis of Gamma-Hydroxybutyrate-induced sleep in intensive care patients: A Pilot Double-Blind Randomized Controlled Trial
EU CTIS ID: 2025-521967-11-00
What this study is testing
The primary objective of this pilot study is to show that the intravenous administration of GHB improves the duration (in minutes) of deep slow-wave sleep (N3 stage) in critically ill adult patients compared to a placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 years or older
- Hospitalized in the ICU for more than 48 hours
- Informed consent obtained from the patient
You likely can't join if
- Unstable patient
- Recent head trauma or neurological injury
- Severe hypertension: SBP > 180 mmHg despite antihypertensive treatment
- Hypokalemia < 3.5 mmol/L despite potassium supplementation
- Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism
- Patients receiving opioids at inclusion for non-mechanically ventilated patient
See the full eligibility criteria
- Aged 18 years or older
- Hospitalized in the ICU for more than 48 hours
- Informed consent obtained from the patient
- Unstable patient
- Recent head trauma or neurological injury
- Severe hypertension: SBP > 180 mmHg despite antihypertensive treatment
- Hypokalemia < 3.5 mmol/L despite potassium supplementation
- Patients with known or suspected succinic semialdehyde dehydrogenase (SSADH) deficiency, given the risk of GHB accumulation due to impaired endogenous metabolism
- Patients receiving opioids at inclusion for non-mechanically ventilated patient
- Patients presenting with hypernatraemia (sodium > 145 mmol/L) or hyperchloraemia (chloride > 110 mmol/L) at inclusion
- Patients with hepatic impairment (Child-Pugh B or C)
- Cardiac conduction disorder
- Obstructive sleep apnea syndrome
- Sodium restriction: Salt intake < 3g/24h
- Lack of social security or on AME (state medical aid)
- Deep sedation defined by a RASS score < -2
- Presence of mental confusion: Positive CAM-ICU
- Moribund patient or high likelihood of death within 48 hours
- Legal protection: guardianship, curatorship, or judicial protection
- Patients receiving barbiturates at inclusion
- Participation in another interventional clinical trial related to the management of sleep disorders, delirium, or sedation in the ICU.
- Known allergy to Gamma-Hydroxybutyrate or any of the exipients
- Technical impossibility of performing polysomnography
- Positive pregnancy test for women of childbearing age or breastfeeding
- Patient who has already received the study treatment
- History of chronic alcoholism
- Uncontrolled epilepsy despite appropriate antiepileptic treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.