Hospitalization in a Post-Resuscitation Rehabilitation Care UnitsCohorte-SRPRNCT03768700
Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)
An observational study of Hospitalization in a Post-Resuscitation Rehabilitation Care Units, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
Trial summary
Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) . Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalization in a Post-Resuscitation Rehabilitation Care Units
- What is being tested?
- Data gathering
- How many people
- 1,000 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Mar 2019to 30 Aug 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen
Who may be able to join
- Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen
Who cannot join
- Refusal of access to the data by the patient or the designated trusted person or the holder (s) of parental authority (pediatric population)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Groupe hospitalier des portes de l'Oise
Beaumont-sur-Oise, 95260
Eric BOUDET, Dr, eric.boulet@ch-pontoise.fr
- Not yet recruiting
Centre hospitalier de Bligny
Briis-sous-Forges, 91640
Henry MAAS, Dr, h.maas@chbligny.fr
- Not yet recruiting
Hôpital d'instruction des armées - Percy
Clamart, 92190
David ROGEZ, Dr
- Not yet recruiting
Hôpital de Forcilles
Férolles-Attilly, 77150
Laurence DONETTI, Dr, ldonetti@cognac-jay.fr
- Not yet recruiting
Hôpital Raymond Poincaré - SRPR pédiatrique
Garches, 92380
Blaise MBIELEU, Dr, blaise.mbieleu@aphp.fr
- Not yet recruiting
Hôpital Raymond Poincaré de Garches - SRPR neurologique
Garches, 92380
Julie PAQUEREAU, Dr, julie.paquereau@aphp.fr
- Not yet recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Bernard VIGUE, Dr, bernard.vigue@aphp.fr
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Alexandre DEMOULE, Pr, 0142167727, alexandre.demoule@aphp.fr
Julie DELEMAZURE, Dr, 0184827572, julie.delemazure@aphp.fr
- Not yet recruiting
Hôpital Sainte-Anne
Paris, 75014
Florence COLLE, Dr, f.colle@ch-sainte-anne.fr
- Not yet recruiting
Hôpital Charles-Nicolle - CHU de Rouen
Rouen, 76000
Gaëtan BEDUNEAU, Dr, Gaetan.beduneau@chu-rouen.fr
About this study
Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) .
Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their hospitalization from hospital reports or call of the attending physician.
Read the detailed description
For one year, all patients, adults and children hospitalized in a post-intensive care rehabilitation unit (SRPR) of Ile de France and Rouen will be offered to participate in the SRPR Cohort in order to have a completeness of data on a new practice.
The study of these data will make it possible to know the future of the patients and to establish criteria prior to the admission in the SRPR which could make it possible to predict this future and to select the patients as well as possible. It will also make it possible to know the impact of care on the outcome of patients at discharge, at 28 days, 90 days and 1 year of their admission to SRPR to improve practices.
This research will focus on the collection of data from patients' medical records. General information about their stay in the intensive care unit - including the patient's ventilatory status - will be collected upon arrival at the SRPR units, during their stay (weekly follow-up), at the exit of the SRPR, at D28, and in the longer term. (J90 and J365 of the entry into the SRPR unit) where will be listed more comprehensive data with, in addition to general information, data on nutritional, neurological, neuromuscular, respiratory and biological hemodynamic assessments will be collected.
In addition to the common data base, each type of SRPR (respiratory and pediatric neurology) will collect data that is specific to its specialty.
- Being tested
- Data gathering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data gatheringOther
Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) Receives: Other: Data gathering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation status of patients discharged from SRPR
Describe the ventilatory status of patients hospitalized in SRPR at the SRPR exit: during the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
Measured: 28 days
Secondary outcomes (7)
Functional status assessed by the functional independence measurement scale (MIF) at entry to the SRPR and weekly follow-up during the stay and discharge of the SRPR, at discharge from the hospital, at Day 28, Day 90 and at 1 year.
Describe the clinico-biological characteristics of patients prior to admission to SRPRs and their future in order to better select them.
Measured: one year
Vital status at the exit of the SRPR at Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
The only one parameters that we will measure will be vital status: alive or not?
Measured: Between the exit of the SRPR and up to one year after entry into the SRPR unit
Ventilatory status at discharge from the hospital, Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
During the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
Measured: Between the exit of the SRPR and up to one year after entry into the SRPR unit
Length of stay in intensive care unit, SRPR and hospital
Measured: one year
Evaluation of swallowing of patients
Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
Measured: one day
Evaluation of nutrition of patients
Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
Measured: one day
Evaluation of nutritional status of patients
Evaluate by clinical data recorded in the medical file: weight in kilograms, height in meters and a combined BMI= weight/height in kg/m^2) and measurement of albumin (g/l) and measurement of prealbuminemia (g/l) at upon entry into SRPR service.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start15 Mar 2019
- Primary completion15 Mar 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalization in a Post-Resuscitation Rehabilitation Care UnitsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre DEMOULE, Pr, Principal investigator, Hôpital Pitié-Salpêtrière - AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768700
- Sponsor's protocol ID
- NI17008J
- Other IDs
- 2018-A00743-52
- Acronym
- Cohorte-SRPR
- Status last verified
- Mar 2023
- First submitted
- 22 Oct 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)
- ClinicalTrials.gov ID
- NCT03768700
- Acronym / sponsor ID
- Cohorte-SRPR / NI17008J
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) .
Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their hospitalization from hospital reports or call of the attending physician.
Detailed description
For one year, all patients, adults and children hospitalized in a post-intensive care rehabilitation unit (SRPR) of Ile de France and Rouen will be offered to participate in the SRPR Cohort in order to have a completeness of data on a new practice.
The study of these data will make it possible to know the future of the patients and to establish criteria prior to the admission in the SRPR which could make it possible to predict this future and to select the patients as well as possible. It will also make it possible to know the impact of care on the outcome of patients at discharge, at 28 days, 90 days and 1 year of their admission to SRPR to improve practices.
This research will focus on the collection of data from patients' medical records. General information about their stay in the intensive care unit - including the patient's ventilatory status - will be collected upon arrival at the SRPR units, during their stay (weekly follow-up), at the exit of the SRPR, at D28, and in the longer term. (J90 and J365 of the entry into the SRPR unit) where will be listed more comprehensive data with, in addition to general information, data on nutritional, neurological, neuromuscular, respiratory and biological hemodynamic assessments will be collected.
In addition to the common data base, each type of SRPR (respiratory and pediatric neurology) will collect data that is specific to its specialty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: Data gatheringHospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen
Key inclusion criteria (1 listed)
- Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen
Key exclusion criteria (1 listed)
- Refusal of access to the data by the patient or the designated trusted person or the holder (s) of parental authority (pediatric population)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data gatheringQuestionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year | Other | Cohort |
Primary outcome
Ventilation status of patients discharged from SRPR
Time frame: 28 days
Describe the ventilatory status of patients hospitalized in SRPR at the SRPR exit: during the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
7 secondary outcomes
Functional status assessed by the functional independence measurement scale (MIF) at entry to the SRPR and weekly follow-up during the stay and discharge of the SRPR, at discharge from the hospital, at Day 28, Day 90 and at 1 year.
Time frame: one year
Vital status at the exit of the SRPR at Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
Time frame: Between the exit of the SRPR and up to one year after entry into the SRPR unit
Ventilatory status at discharge from the hospital, Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
Time frame: Between the exit of the SRPR and up to one year after entry into the SRPR unit
Length of stay in intensive care unit, SRPR and hospital
Time frame: one year
Evaluation of swallowing of patients
Time frame: one day
Evaluation of nutrition of patients
Time frame: one day
Evaluation of nutritional status of patients
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre DEMOULE, Pr principal investigator
Hôpital Pitié-Salpêtrière - AP-HP
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization in a Post-Resuscitation Rehabilitation Care Units, run by Assistance Publique - Hôpitaux de Paris at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre DEMOULE, Pr (0142167727, alexandre.demoule@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation status of patients discharged from SRPR (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.