Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR) (Cohorte-SRPR)
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| ClinicalTrials.gov Identifier: NCT03768700 |
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Recruitment Status :
Recruiting
First Posted : December 7, 2018
Last Update Posted : September 10, 2021
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Hospitalization in a Post-Resuscitation Rehabilitation Care Units | Other: Data gathering |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR) |
| Actual Study Start Date : | March 15, 2019 |
| Estimated Primary Completion Date : | March 15, 2022 |
| Estimated Study Completion Date : | August 30, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cohort
Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR)
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Other: Data gathering
Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year |
- 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?
- 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 ]Describe the clinico-biological characteristics of patients prior to admission to SRPRs and their future in order to better select them.
- 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 ]The only one parameters that we will measure will be vital status: alive or not?
- 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 ]During the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
- Length of stay in intensive care unit, SRPR and hospital [ Time Frame: one year ]
- Evaluation of swallowing of patients [ Time Frame: one day ]Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
- Evaluation of nutrition of patients [ Time Frame: one day ]Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
- Evaluation of nutritional status of patients [ Time Frame: one day ]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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen
Exclusion Criteria:
- Refusal of access to the data by the patient or the designated trusted person or the holder (s) of parental authority (pediatric population)
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): NCT03768700
| Contact: Alexandre DEMOULE, Pr | 0142167727 | alexandre.demoule@aphp.fr | |
| Contact: Julie DELEMAZURE, Dr | 0184827572 | julie.delemazure@aphp.fr |
| France | |
| Groupe hospitalier des portes de l'Oise | Not yet recruiting |
| Beaumont-sur-Oise, France, 95260 | |
| Contact: Eric BOUDET, Dr eric.boulet@ch-pontoise.fr | |
| Centre hospitalier de Bligny | Not yet recruiting |
| Briis-sous-Forges, France, 91640 | |
| Contact: Henry MAAS, Dr h.maas@chbligny.fr | |
| Hôpital d'instruction des armées - Percy | Not yet recruiting |
| Clamart, France, 92190 | |
| Contact: David ROGEZ, Dr | |
| Hôpital de Forcilles | Not yet recruiting |
| Férolles-Attilly, France, 77150 | |
| Contact: Laurence DONETTI, Dr ldonetti@cognac-jay.fr | |
| Hôpital Raymond Poincaré - SRPR pédiatrique | Not yet recruiting |
| Garches, France, 92380 | |
| Contact: Blaise MBIELEU, Dr blaise.mbieleu@aphp.fr | |
| Hôpital Raymond Poincaré de Garches - SRPR neurologique | Not yet recruiting |
| Garches, France, 92380 | |
| Contact: Julie PAQUEREAU, Dr julie.paquereau@aphp.fr | |
| Hôpital Bicêtre | Not yet recruiting |
| Le Kremlin-Bicêtre, France, 94270 | |
| Contact: Bernard VIGUE, Dr bernard.vigue@aphp.fr | |
| Hôpital Pitié-Salpêtrière | Recruiting |
| Paris, France, 75013 | |
| Contact: Alexandre DEMOULE, Pr 0142167727 alexandre.demoule@aphp.fr | |
| Contact: Julie DELEMAZURE, Dr 0184827572 julie.delemazure@aphp.fr | |
| Hôpital Sainte-Anne | Not yet recruiting |
| Paris, France, 75014 | |
| Contact: Florence COLLE, Dr f.colle@ch-sainte-anne.fr | |
| Hôpital Charles-Nicolle - CHU de Rouen | Not yet recruiting |
| Rouen, France, 76000 | |
| Contact: Gaëtan BEDUNEAU, Dr Gaetan.beduneau@chu-rouen.fr | |
| Principal Investigator: | Alexandre DEMOULE, Pr | Hôpital Pitié-Salpêtrière - AP-HP |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT03768700 |
| Other Study ID Numbers: |
NI17008J 2018-A00743-52 ( Other Identifier: ANSM ) |
| First Posted: | December 7, 2018 Key Record Dates |
| Last Update Posted: | September 10, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |