A Phase 3 interventional study of Administration of AVP and Administration of placebo AVP in Postresuscitation Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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Among 11 studies in Diabetes Insipidus with a site in France — 2 open to participants now, 3 under way, 1 of them phase 3. Diabetes Insipidus · France.
Among the 11 studies in Diabetes Insipidus with a site in France, this one is one of 2 that started in 2021, is the only one in phase 3, and was the 7th registered.
191 studies on the registry are indexed under Diabetes Insipidus; 35 are open to participants now.
Browse Diabetes Insipidus studies →2 of the 11 studies in Diabetes Insipidus with a site in France are open now. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 30 Diabetes Insipidus studies recruiting now, 16 (53%) set no upper age limit and 11 (37%) stop at 75 or younger; 4 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2021.
This study's planned enrollment of 380 is above the median of 77 across 118 interventional studies indexed under Diabetes Insipidus.
Median enrollment 100 across the 5 interventional studies, 200 across the 6 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 9 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 2 studies filed under Diabetes Insipidus — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Diabetes Insipidus with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The primary objective is to demonstrate the superiority of arginine-vasopressin (AVP) and hydrocortisone compared with norepinephrine regarding day-30 survival and neurological recovery in post-cardiac arrest patients with hemodynamic failure.
For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting.
This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF.
Investigational medicinal products:
AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days.
Comparator treatment: placebos.
17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
REVERPLEG® 40 IU/2mL+ Placebo of hydrocortisone.
Drug: Administration of AVP · Drug: Administration of placebo hydrocortisone
Placebo of REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.
Drug: Administration of placebo AVP · Drug: Administration of hydrocortisone
REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.
Drug: Administration of AVP · Drug: Administration of hydrocortisone
Placebo of REVERPLEG® 40 IU/2mL + placebo of hydrocortisone
Drug: Administration of placebo AVP · Drug: Administration of placebo hydrocortisone
Administration of AVP
Administration of placebo AVP
Administration of placebo hydrocortisone
Administration of hydrocortisone
Neurological outcome
The primary endpoint will be the good neurological outcome at day-30. This will be evaluated using the Glasgow Outcome Scale (GOS, addendum 18.5.1) dichotomized as follow: good neurological outcome for categories 4 and 5 and poor neurological outcome or death for categories 3, 2 and 1. The GOS will be obtained at day-30 from an in-hospital visit if the patient is still hospitalized or from telephone contact with patients, relatives or general practitioners.
Time frame: at day-30
All-cause mortality
Vital status at day-30.
Time frame: at day-30
Mortality attributed to irreversible hemodynamic failure
Time to irreversible cardiovascular failure defined as death in pharmacologically uncontrollable hypotension (mean arterial blood pressure \< 60 mmHg) despite maximal ICU care, or withdrawal of care based on same, as previously defined (Witten L, Resuscitation 2019).
Time frame: at day-30
Mortality attributed to neurological withdrawal of care
Time to neurological withdrawal of care. Withdrawal of care will be based on expectations of a poor neurological recovery based on most recent guidelines (Sandroni C, ICM 2015).
Time frame: at day-30
Mortality attributed to comorbid withdrawal of care
Time to comorbid withdrawal of care. Comorbid withdrawal of care or refusal of life-sustaining therapy based on the expectation of a poor quality of life. This may be related to a preexisting or newly discovered terminal illness or other serious medical condition (e.g. dementia or cancer).
Time frame: at day-30
Day-30 brain death
Time to brain death (according to French legislation)
Time frame: at day-30
mortality attributed to recurrent cardiac arrest
Time to recurrent cardiac arrest
Time frame: at day-30
Other causes
Proportion of patients dead from a cause not listed above.
Time frame: at day-30
Neurological recovery at day-30
Glasgow outcome score - extended at day-30. This score will be evaluated similarly to the primary endpoint
Time frame: at day-30
Brain damage
Neuron-specific enolase (NSE) blood level measured 48 and 72 hours after CA
Time frame: at 48 hours and at 72hours
Not enrolling at this site.
Plan to share: No
Started May 2021 (actual). Primary completion is estimated for Dec 2025, 55 months after the start.
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