Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-16 @ 4:39 PM
Study NCT ID:
NCT07290712
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICS-DACH
Brief Summary:
Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Affected patients and their families (PICS-F) face significant burdens, with up to 94% of relatives impacted. Given its high prevalence and socioeconomic impact, this prospective registry study aims to identify risk factors and long-term consequences of PICS and PICS-F.
The study consists of six modules, starting with data collection during ICU stays and continuing with follow-ups at various intervals post-discharge (up to five years). The primary goal is to investigate diagnostic and therapeutic strategies, while secondary objectives include identifying risk factors, determining impairment severity, and exploring biological mechanisms. Standardized questionnaires and biological samples (blood) are used for data collection.
The study consists of six modules, starting with data collection during ICU stays and continuing with follow-ups at various intervals post-discharge (up to five years). The primary goal is to investigate diagnostic and therapeutic strategies, while secondary objectives include identifying risk factors, determining impairment severity, and exploring biological mechanisms. Standardized questionnaires and biological samples (blood) are used for data collection.
Detailed Description:
BACKGROUND Post-Intensive Care Syndrome (PICS) refers to newly occurring or intensified cognitive, physical, and psychological long-term effects, as well as pain and socioeconomic effects resulting from intensive care treatment. Symptoms can appear as early as 24 hours after admission to the intensive care unit (ICU) and persist for 5-15 years after discharge. The rate of affected individuals is very high. Three months after discharge due to an illness requiring intensive care, 64% of survivors were impaired in at least one of the three functional areas, and 56% were impaired after 12 months. The hospitalization of a close relative in the ICU affects the entire family system, i.e., all people with whom the patients have a significant relationship. The effects on the family or relatives are referred to as Post-Intensive Care Syndrome-Family (PICS-F), which represents a significant burden for up to 94% of relatives. PICS and PICS-F are therefore of high socioeconomic importance.
RELEVANCE Given the significant impact of PICS on patients, their families, and the socioeconomic system, gaining insights into the prevalence of risk factors and PICS criteria during ICU stay, as well as PICS and PICS-F after ICU discharge and hospital release, is highly valuable.
DESIGN
The study is divided into the following six modules:
1. ICU module
2. Post-ICU module 2: a) 1-3 months + 6 months, b) 1, 2, 5 years
3. Environment module
4. Psychiatry module
5. Translational module
6. Family system module (PICS-F) The participating centers take part in at least the first module, the ICU module, in which the risk factors and PICS as well as PICS-F domains are recorded during the intensive care stay. Depending on local conditions, capacity, and resources, the participating centers optionally participate in modules 2 to 6. In the individual modules, there is also the option of participating in a mode available to all centers or specialized for individual centers (e.g., functional tests that can only be performed in a PICS outpatient clinic (PICA)). For centers without PICA, follow-up observation is carried out, for example, via questionnaires. The corresponding mode of participation with and without PICA is displayed accordingly in the individual modules.
PRIMARY OBJECTIVE
• The primary objective of the prospective registry is to record and investigate the risk factors, diagnostic and therapeutic options for PICS and PICS-F.
SECONDARY OBJECTIVES
* Recording the frequency of multiple risk factors for and the manifestation of PICS and PICS-F during and after treatment in an intensive care unit.
* Recording the rate of risk factors, especially the modifiable risk factors of PICS in different disease entities, such as sepsis, delirium, and other underlying diseases requiring intensive care.
* Determination of cut-off values and rates of significant cognitive, physical and psychological impairments as well as pain.
* Assessment of the significance for PICS between and within individual dimensions of PICS.
* Estimation of incidence based on risk factors or different cut-off values for scores to define significant limitations at the cognitive, physical and psychological levels as well as chronic pain.
* Determination and investigation of the influence of relevant external and internal environmental factors that contribute to the development and course of PICS/PICS-F.
* Identification of molecular biological or pathophysiological processes of PICS.
PROCEDURE
1. Examination using standardized questionnaires during intensive care. The aim is to record cognitive, physical, and psychological functional impairments as well as pain (= PICS and PICS-F rates) while still in the intensive care unit. The patient and their relatives and friends are interviewed.
2. Follow-up examination using standardized questionnaires in the PICS outpatient clinic 1-3 and 6 months after discharge from the intensive care unit. The aim of these appointments is to record cognitive, physical, and psychological functional impairments as well as pain.
3. Completion of standardized questionnaires to record cognitive, physical, and psychological functional impairments as well as pain (1, 2, and 5 years after discharge from the intensive care unit; this can be done by telephone, electronically, by mail, via telemedicine, or in PICA).
4. Blood samples for the creation of a biobank (depending on follow-up appointments at the PICS study outpatient clinic: 4-7x 27ml each; timing: during ICU (inclusion (\> 72h ICU stay) and ICU discharge), 1-3 months, 6 months and, if applicable, 1, 2, and 5 years after ICU discharge.
RELEVANCE Given the significant impact of PICS on patients, their families, and the socioeconomic system, gaining insights into the prevalence of risk factors and PICS criteria during ICU stay, as well as PICS and PICS-F after ICU discharge and hospital release, is highly valuable.
DESIGN
The study is divided into the following six modules:
1. ICU module
2. Post-ICU module 2: a) 1-3 months + 6 months, b) 1, 2, 5 years
3. Environment module
4. Psychiatry module
5. Translational module
6. Family system module (PICS-F) The participating centers take part in at least the first module, the ICU module, in which the risk factors and PICS as well as PICS-F domains are recorded during the intensive care stay. Depending on local conditions, capacity, and resources, the participating centers optionally participate in modules 2 to 6. In the individual modules, there is also the option of participating in a mode available to all centers or specialized for individual centers (e.g., functional tests that can only be performed in a PICS outpatient clinic (PICA)). For centers without PICA, follow-up observation is carried out, for example, via questionnaires. The corresponding mode of participation with and without PICA is displayed accordingly in the individual modules.
PRIMARY OBJECTIVE
• The primary objective of the prospective registry is to record and investigate the risk factors, diagnostic and therapeutic options for PICS and PICS-F.
SECONDARY OBJECTIVES
* Recording the frequency of multiple risk factors for and the manifestation of PICS and PICS-F during and after treatment in an intensive care unit.
* Recording the rate of risk factors, especially the modifiable risk factors of PICS in different disease entities, such as sepsis, delirium, and other underlying diseases requiring intensive care.
* Determination of cut-off values and rates of significant cognitive, physical and psychological impairments as well as pain.
* Assessment of the significance for PICS between and within individual dimensions of PICS.
* Estimation of incidence based on risk factors or different cut-off values for scores to define significant limitations at the cognitive, physical and psychological levels as well as chronic pain.
* Determination and investigation of the influence of relevant external and internal environmental factors that contribute to the development and course of PICS/PICS-F.
* Identification of molecular biological or pathophysiological processes of PICS.
PROCEDURE
1. Examination using standardized questionnaires during intensive care. The aim is to record cognitive, physical, and psychological functional impairments as well as pain (= PICS and PICS-F rates) while still in the intensive care unit. The patient and their relatives and friends are interviewed.
2. Follow-up examination using standardized questionnaires in the PICS outpatient clinic 1-3 and 6 months after discharge from the intensive care unit. The aim of these appointments is to record cognitive, physical, and psychological functional impairments as well as pain.
3. Completion of standardized questionnaires to record cognitive, physical, and psychological functional impairments as well as pain (1, 2, and 5 years after discharge from the intensive care unit; this can be done by telephone, electronically, by mail, via telemedicine, or in PICA).
4. Blood samples for the creation of a biobank (depending on follow-up appointments at the PICS study outpatient clinic: 4-7x 27ml each; timing: during ICU (inclusion (\> 72h ICU stay) and ICU discharge), 1-3 months, 6 months and, if applicable, 1, 2, and 5 years after ICU discharge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: