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Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR) (Cohorte-SRPR)

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ClinicalTrials.gov Identifier: NCT03768700
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 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

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.


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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, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
Cohort
Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR)
Other: Data gathering
Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year




Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. 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.

  2. 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?

  3. 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?

  4. Length of stay in intensive care unit, SRPR and hospital [ Time Frame: one year ]
  5. Evaluation of swallowing of patients [ Time Frame: one day ]
    Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.

  6. Evaluation of nutrition of patients [ Time Frame: one day ]
    Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.

  7. 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
Study Population
Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Alexandre DEMOULE, Pr 0142167727 alexandre.demoule@aphp.fr
Contact: Julie DELEMAZURE, Dr 0184827572 julie.delemazure@aphp.fr

Locations
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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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alexandre DEMOULE, Pr Hôpital Pitié-Salpêtrière - AP-HP

Additional Information:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03768700     History of Changes
Other Study ID Numbers: NI17008J
2018-A00743-52 ( Other Identifier: ANSM )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No