DELirium, Incidence, preVEntion and pRogression During Ac... | NCT07070310

Studies
DELirium, Incidence, preVEntion and pRogression During Acute Intensive Neurological -Neurosurgical Rehabilitation

NCT07070310

Sponsor

Heart Centre Rotenburg

Status

Not yet recruiting

Last Update Posted

Jul 22, 2025Actual

Enrollment

210Estimated

Phase

Not provided

Conditions

Neurological Conditions

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2025Estimated

Primary Completion Date

Aug 15, 2028Estimated

Completion Date

Feb 15, 2029Estimated

First Submitted Date

Jul 8, 2025

First Submission Date that Met QC Criteria

Jul 16, 2025

First Posted Date

Jul 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2025

Last Update Posted Date

Jul 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ralf Degenhardt, PhD, Head of Clinical Research Institute, Heart Centre RotenburgPrincipal Investigator

Lead Sponsor

Heart Centre RotenburgOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this longitudinal cohort study the incidence of delirium is assessed for all patients being admitted to the acute intensive neurological-neurosurgical rehabilitation over 3 years. Delirium assessment will be performed daily from admission to discharge. Patients will be divided into 3 groups, according to the presentation of delirium on admission, during the course or not any during the stay in acute rehabilitation and compared regarding the treatment and outcome.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Measure	Description	Time Frame
incidence of delirium		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient admitted to acute neurological-seurosurgical rehabilitation

Exclusion Criteria:

: patients with level of consciousness of coma or vegetative state

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in Neurosurgical rehabilitation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroline Renner, Priv.-Doz. Dr. med	Contact	+49-6623-88-0		c.renner@hkz-rotenburg.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg GmbH, Klinik für Neurologie und Neurologische Rehabilitation		Rotenburg an der Fulda		36199	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided