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Frailty SyndromeNCT04880824

Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)

An observational study of Frailty Syndrome, run by Charite University, Berlin, Germany at 27 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The patients included in PRÄP-GO and the corresponding comparison cohorts will be offered to participate in this complementary study in order to be able to carry out a detailed characterization and phenotyping of the frailty complex. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Frailty Syndrome
What is being tested?
Prehabilitation- new form of care
How many people
693 participants
Where
27 sitesGermany
Study dates
19 May 2021to 21 Mar 2025
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 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: The groups of participants in this scientific accompanying program ANA-PRÄP-GO are: * Randomized study patients with a frailty syndrome of the intervention study PRÄP-GO (PG cohort) * Non-frail surgical control group (NFC cohort) * Non-surgical comparison group (NO cohort) * Participants with health professions (GB cohort) * Relatives of the included patients

Who may be able to join

  • Consent given and inclusion in PRÄP-GO
  • Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
  • Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
  • Age ≥ 70 years
  • Elective surgery planned
  • Expected anesthesia duration> 60 min
Show all 13Show fewer
  • No frailty syndrome (0 positive out of 5 standardized parameters) according to the physical frailty phenotype (Fried et al., 2001)
  • Age ≥ 70 years
  • No elective surgery planned
  • No surgery within 6 months prior to study enrollment
  • Doctor, nurse or therapist from the cooperation partners of PRAEP-GO who were involved in the project
  • Member of a patient in the PRÄP-GO cohort
  • Age ≥ 18 years

Who cannot join

  • None
  • NFC cohort:
  • Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
  • Intracranial interventions
  • Moribund patients (palliative situation)
  • Patients with a neuropsychiatric clinical picture or severe hearing and / or visual acuity impairment (not compensated by visual or hearing aids), which limit the performance of the neurocognitive tests
Show all 13Show fewer
  • Insufficient language skills
  • Participation in another interventional rehabilitation study or a study according to the German Drug Law or the medical Device Law that has not been approved by the study leader (Exception: parallel participation in adjuvant therapy study).
  • NO cohort:
  • GB cohort:
  • Language barrier
  • Relatives:
  • Language barrier

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Germany27 sites
  • Charité-Universitätsmedizin Berlin, Department of Physical Medicine

    Berlin, 10117

  • Praxis Landgraf

    Berlin, 12163

  • Department of Anesthesiology and Operative Intensive Care Medicine (CBF)

    Berlin, 12203

  • Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine

    Berlin, 13353

  • Paul Gerhard Diakonie - Evangelisches Waldkrankenhaus Spandau

    Berlin, 13589

  • Paul Gerhard Diakonie - Evangelisches Krankenhaus Hubertus

    Berlin, 14129

  • Paul Gerhard Diakonie - Martin-Luther-Krankenhaus

    Berlin, 14193

  • Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

    Berlin

  • CARITAS Klinik Maria Heimsuchung

    Berlin

  • Dominikus-Krankenhaus

    Berlin

  • Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

    Berlin

  • Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH

    Berlin

  • Sankt Jospeph Krankenhaus

    Berlin

  • Unfallkrankenhaus Berlin

    Berlin

  • Universitätsklinikum Mannheim GmbH

    Berlin

  • Wenckebach-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

    Berlin

  • Carl-Thiem-Klinikum

    Cottbus

  • Werner Forßmann-Krankenhaus

    Eberswalde

  • Klinikum Frankfurt Oder GmbH

    Frankfurt (Oder)

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Asklepios Klinikum Harburg

    Harburg

  • Sana Kliniken Sommerfeld

    Kremmen

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck

    Lübeck

  • Klinikum der Universität München, LMU Campus Großhadern

    München

  • Klinikum rechts der Isar - Technische Universität München

    München

  • München Klinik Bogenhausen

    München

  • Praxis Prof. Dr med. Ulrich Schwantes

    Schwante, Brandenburg, 16727

Other trials in Germany

About this study

Official title: Analysis of the Pathophysiology of Frailty Syndrome and Clinical Development of Frailty Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)

The patients included in PRÄP-GO and the corresponding comparison cohorts will be offered to participate in this complementary study in order to be able to carry out a detailed characterization and phenotyping of the frailty complex.

Amendment vote of 08/05/2024: Recruitment extension of Non-frail surgical control group (NFC cohort) until August 31, 2025.

Read the detailed description

As part of the innovation fund project PRÄP-GO (EA1/225/19), a multimodal intervention is being conducted in patients with a frailty syndrome. However, the health care research project is limited to evaluating clinical issues only. In order to be able to research further pathophysiological, clinical, psychosocial and work-organizational connections, different groups of participants will be offered the participation in this scientific support program of PRÄP-GO.

The groups of participants in this accompanying program ANA-PRÄP-GO are:

  • Randomized study patients with a frailty syndrome of the intervention study PRÄP-GO (PG cohort)
  • Non-frail surgical control group (NFC cohort)
  • Non-surgical comparison group (NO cohort)
  • Participants with health professions (GB cohort)

Additionally, relatives of the patients can be included.

Subprojects are included to reflect research questions of interest in sub groups:

  • Success of endoprosthetic implants (clinical outcome and gait pattern after total hip arthroplasty and total knee arthroplasty in frail patients)
  • Functional treatment outcome and health-related quality of life after elective spinal surgery in the PG cohort, in the NFC cohort, and in the NO cohort
  • Hemodynamic evaluation in patients of the PG and NFC cohort with preoperative abnormal cardiovascular function
  • Establishment of a German standard database for 14 CANTAB tests by CANTAB Connect technology
  • Aggregated evaluation of the cognitive data of different surgical cohorts from studies carried out at the department of anesthesiology to describe domain-specific changes in the perioperative course
  • Perspectives of different health professional groups regarding barriers and facilitators in the implementation of a prehabilitation program and necessary changes in skill, organizational and management, and communication in an interdisciplinary setting
  • Perspectives of patients and significant others regarding the organizational pathway of the prehabilitation program
  • Frequency, pathophysiology and trajectory of muscle weakness as well as functional impairments of patients admitted to intensive care units of the PG and NFC cohort and their long-term outcomes.
  • The gut microbiome as a potential risk factor for perioperative neurocognitive disorders (PNDs) in the elderly
  • Evaluation of nutrition data in all cohorts (e.g. adherence to mediterranean diet, nutrition habits, nutritional status, dental status etc.)
Being tested
Prehabilitation- new form of care
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prehabilitation- new form of careBehavioural

    The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.

Study groups in NCT04880824
Study groupRoleWhat they receive
PG cohort800 randomized surgical study patients with a frailty syndrome (Pre-frail and frail) of the intervention study PRÄP-GO (PG cohort). 400 study patients receive the intervention and 400 study patients receive standard of care.
Receives: Behavioral: Prehabilitation- new form of care
NFC cohort400 non-frail surgical control group (NFC cohort)
NO cohort300 non-operative control group (NO cohort)
GB cohortSkill-Change-Management: a maximum of 30 coworkers and analysis of guiding principle: to a maximum of 35 patients, 30 relatives and 45 coworkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty

    Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)

    Measured: Up to 1 year

  2. Neuro-cognitive disorder (NCD)

    Frequency of neuro-cognitive disorder (mild / major NCD)

    Measured: Up to 1 year

Secondary outcomes (84)
  1. Incidence of delirium

    Incidence of delirium, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Richmond Agitation Scale (RASS), Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), along with the delirium severity scores Confusion Assessment Method Severity-Score (CAM-S) in English, Intensive Care Delirium Screening Checklist (ICDSC), Delirium Rating Scale Revised 98 (DRS-R-98) in English and patient chart review. The assessment period is from the recovery room up to five postoperative days or until hospital discharge.

    Measured: During the hospital stay, an expected average of 1 week

  2. Severity of delirium

    Severity of delirium defined as a composite score based on: Confusion Assessment Method Severity-Score(CAM-S); Confusion Assessment Method (CAM), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Delirium Rating Scale Revised (DSR-R-98) in English, Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC) and patient chart review.

    Measured: During the hospital stay, an expected average of 1 week

  3. Nursing Delirium Screening Scale (Nu-DESC)

    Nursing Delirium Screening Scale (Nu-DESC) score of ≥ 2 is indicative of delirium, range: 0-10 points, 10 = most severe.

    Measured: During the hospital stay, an expected average of 1 week

  4. Confusion Assessment Method (CAM)

    Confusion Assessment Method (CAM) score is indicative of delirium, if the items 1 and 2 and 3 or the items 1 and 2 and 4 are measured positively.

    Measured: During the hospital stay, an expected average of 1 week

  5. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

    Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score is indicative of delirium, if the items 1 and 2 and 3 or the items 1 and 2 and 4 are measured positively.

    Measured: During the hospital stay, an expected average of 1 week

  6. Confusion Assessment Method Severity-Score (CAM-S Long Form) in English

    The Confusion Assessment Method Severity-Score (CAM-S Long Form) is an 10-item delirium screening instrument (range: 0-19 points, 19 = most severe).

    Measured: During the hospital stay, an expected average of 1 week

  7. Intensive Care Delirium Screening Checklist (ICDSC)

    The ICDSC is an 8-item delirium screening instrument (range: 0-8 points). The score is indicative of delirium, if the item is > 3.

    Measured: During the hospital stay, an expected average of 1 week

  8. Delirium Rating Scale Revised 98 in English (DRS-R-98)

    The delirium rating scale revised 98 is a delirium screening instrument (range 0-46). The score is indicative of delirium, if the item is > 14.5.

    Measured: During the hospital stay, an expected average of 1 week

  9. Delirium Severity Scale (CAM-ICU-7) in English

    A 7-point rating scale (0-7) was derived from the CAM-ICU and RASS assessments 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.

    Measured: During the hospital stay, an expected average of 1 week

  10. Number of Participants with Delirium as Determined by Chart Review

    Delirium is identified chart-based.

    Measured: During the hospital stay, an expected average of 1 week

  11. Delirium days

    The duration of delirium is measured in days.

    Measured: During the hospital stay, an expected average of 1 week

  12. COVID-19

    SARS-CoV-2 infection

    Measured: Up to 1 year

  13. Cardiovascular function 1

    Cardiovascular function is measured by Transesophageal Echocardiography.

    Measured: Up to 1 year

  14. Cardiovascular function 2

    Cardiovascular function is measured by cardiovascular complications.

    Measured: Up to 1 year

  15. Ethical aspects

    Wishes of the patient about the intensity of therapy and therapy goals are measured with a questionnaire.

    Measured: Up to 1 year

  16. Patient satisfaction

    Patient satisfaction score is measured with a likert scale (0 - 10)

    Measured: Up to 1 year

  17. Patient-related outcome measures (PROMS)

    Different tools and questionnaires are combined to measure Patient-related outcome.

    Measured: Up to 1 year

  18. Patient-related experience measures (PREMS)

    Patient-reported experiences of health care are measured with a questionnaire.

    Measured: Up to 1 year

  19. Incidence of dementia

    incidence of dementia is measured by MOCA

    Measured: Up to 1 year

  20. Incidence of cognitive impairment

    incidence of cognitive impairment is measured by a validated score.

    Measured: Up to 1 year

  21. Findings of Memory consultation

    During memory consultation cognitive diagnostic findings are measured.

    Measured: Up to 1 year

  22. Stress

    Stress is measured by Perceived Stress Questionnaire (PSQ20), which ranges from 20-80 points

    Measured: Up to 1 year

  23. Anxiety 1

    Anxiety is measured by Generalized Anxiety Disorder 7, points range from 0-21

    Measured: Up to 1 year

  24. Anxiety 2

    Anxiety 2 is measured by Faces Anxiety Scale, a valid single-item for self-report measure of state

    Measured: Up to 1 year

  25. Insomnia

    Insomnia is measured by Insomnia Severity Index (ISI), which ranges from 0- 21 points

    Measured: Up to 1 year

  26. Neuroimaging

    Routine neuroimaging results were planned to be documented in the hospital including all techniques to image the nervous system as ultrasound, magnetic resonance imaging, conventional radiography, computed tomography and positron emission tomography.

    Measured: Up to 1 year

  27. Demand of health services

    The need of treatment for curing an illness.

    Measured: Up to 1 year

  28. Adverse events

    Adverse events are measured in all participants, who receive study measurements

    Measured: Up to 1 year

  29. Nutritional Status

    Changes in the nutritional status after elective surgery

    Measured: Up to 1 year

  30. Adherence to Mediterranean diet (MD)

    Adherence to Mediterranean diet (MD) is measured with a German Medi-Score, could range from 0 to 9, with higher scores (6-9) indicating greater MD adherence.

    Measured: Up to 1 year

  31. Sarcopenia

    The composite outcome measure "Sarcopenia" is defined by the following three criteria: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference and 3) low physical performance (gait speed). Criterion (1) identifies probable sarcopenia, additional documentation of criterion (2) confirms sarcopenia diagnosis, and if all criteria (1), (2) and (3) are met, sarcopenia is considered severe.

    Measured: Up to 1 year

  32. Calf circumference

    Calf circumference is measured in a standardized position and documented in centimeter.

    Measured: Up to 1 year

  33. Arm circumference

    Arm circumference is measured in a standardized position and documented in centimeter.

    Measured: Up to 1 year

  34. Dental status

    (number of teeth, Oral Health Assessment Tool (OHAT), Geriatric Oral Health Assessment Index (GO-HAI), questions regarding prothesis, dentist visits and dental care)

    Measured: Up to 1 year

  35. Quality of life

    Quality of life is measured by Care Related Quality of Life (CarerQoL)

    Measured: Up to 1 year

  36. Postoperative complications

    Complications are measured according to the Clavien-Dindo classification

    Measured: Up to 30 days

  37. Psychometric properties of the Meta Memory questionnaire

    Psychometric properties of the Meta Memory questionnaire are measured twice before surgery.

    Measured: During the hospital stay, at the beginning of the investigation, an average of two hours.

  38. Number of participants with changes in laboratory values 1

    Routine laboratory results were planned to be documented in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count from blood samples.

    Measured: Up to 1 year

  39. Number of participants with changes in laboratory values 2

    Routine laboratory results were planned to be documented from the general practitioner including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count from blood samples.

    Measured: Up to 1 year

  40. APOE polymorphisms

    APOE polymorphisms are measured from whole blood once during hospital stay, an expected average of one week.

    Measured: Up to 1 year

  41. Total interleukin-8

    Total interleukin-8 is measured from whole blood

    Measured: Up to 1 year

  42. Cholinesterases 1

    Acetylcholinesterase and Butyrylcholinesterase are measured from liquor

    Measured: Up to 1 year

  43. Cholinesterases 2

    Acetylcholinesterase and Butyrylcholinesterase are measured from whole blood

    Measured: Up to 1 year

  44. Intracellular pH

    Intracellular pH is measured from whole blood.

    Measured: Up to 1 year

  45. Autophagy of platelets

    Autophagy of platelets is measured from whole blood.

    Measured: Up to 1 year

  46. Peripheral Blood Mononuclear Cell

    Peripheral Blood Mononuclear Cell are measured from whole blood.

    Measured: Up to 1 year

  47. Multiplex gene expression analyzes (neuroinflammation and micro RNA panels)

    Multiplex gene expression analyzes (neuroinflammation and micro RNA panels) are measured from whole blood

    Measured: Up to 1 year

  48. Autoantibodies

    Autoantibodies against beta2-adrenergic receptor, muscarinic acetylcholine receptor (M3 / M4), serotonin receptor, dopamine receptor are measured from serum

    Measured: Up to 1 year

  49. Trypotophan metabolites and short-chain fatty acids

    Trypotophan metabolites and short-chain fatty acids are measured from serum with metabolomic analysis

    Measured: Up to 1 year

  50. Biomarker panel

    Biomarker are measured from serum by metabolomic analyses to characterize the frailty complex.

    Measured: Up to 1 year

  51. Cytokines

    Cytokines (IFN-Ɣ IL-1β IL-4 IL-6 IL-10 IL-17A IL-17E IL-17F IL-21 IL-23 TGF-β1) are measured from plasma

    Measured: Up to 1 year

  52. Chemokines

    Chemokines (CCL2 (MCP-1) CCL3 CCL4 CCL5 (RAN-TES) CCL11 (Eotaxin) CCL19 CCL20 CXCL1 CXCL8 (IL-8) CXCL10 (IP-10) CXCL12 (SDF1A) are measured from plasma

    Measured: Up to 1 year

  53. Markers immune-brain axis and gut-brain axis

    Markers immune-brain axis and gut-brain axis (zonulin, endothelial cell-specific molecule 1, S100A6, S100A8, S100A9, S100P, S100beta, Interleu-kin-16, CD162, BDNF, CD272, p-selectin, be-ta2microglobulin , Haptoglobin, cathelicidin, NCAM-1, BTLA and CXCR5) are measured from plasma

    Measured: Up to 1 year

  54. Protein panel

    Proteins are measured from plasma by proteome analysis.

    Measured: Up to 1 year

  55. Microbiome 1

    Analyzes of bacteria-specific 16S DNA from different biomaterial.

    Measured: Up to 1 year

  56. Microbiome 2

    Analyzes of sequences of known microorganisms from different biomaterial.

    Measured: Up to 1 year

  57. Serum albumin

    Serum albumin is measured from whole blood

    Measured: Up to 1 year

  58. HbA1c

    HbA1c is measured from whole blood

    Measured: Up to 1 year

  59. Vitamin D (cholecalciferol)

    Vitamin D is measured from whole blood

    Measured: Up to 1 year

  60. Dementia markers

    Dementia markers: beta amyloid 1-40, beta-amyloid 1-42, beta-amyloid ratio (42/40 * 10), phospho-TAU, protein 14-3-3, PRPSc, TAU (total tau) are measured from liquor

    Measured: Up to 1 year

  61. Analysis of microbiome

    Microbial diversity is measured from blood, urine and feces (e.g. Shannon index)

    Measured: Up to 1 year

  62. Analysis of urine

    Relative frequency of metabolites is measured in urine

    Measured: Up to 1 year

  63. Biobanks samples

    Secondary use of the biological samples in particular for research purposes

    Measured: Up to 1 year

  64. Hip Osteoarthritis Outcome

    Hip Osteoarthritis Outcome is measured from Hip disability and Osteoarthritis Outcome Score (HOOS) in orthopedic patients from PG cohort

    Measured: Up to 1 year

  65. Knee Osteoarthritis Outcome

    Knee Osteoarthritis Outcome is measured from Knee injury and Osteoarthritis Outcome (KOOS) in orthopedic patients from PG cohort

    Measured: Up to 1 year

  66. Gait analysis 1

    Temporal (e.g.: total activity duration, stance time) parameters are measured in orthopedic patients from PG cohort.

    Measured: Up to 1 year

  67. Gait analysis 2

    Kinetic parameters (e.g.: vertical plantar loading, loading symmetry) are measured in orthopedic patients from PG cohort.

    Measured: Up to 1 year

  68. Range of Motion of the hip/knee

    Range of Motion of the hip/knee is measured during orthopedic investigation of PG cohort patients

    Measured: Up to 1 year

  69. Hip abduction force (for total hip arthroplasty patients)

    Hip abduction force is measured during orthopedic investigation of PG cohort patients

    Measured: Up to 1 year

  70. Knee extension and flexion force measurement (for total knee arthroplasty patients)

    Knee extension and flexion force measurement is measured during orthopedic investigation of PG cohort patients

    Measured: Up to 1 year

  71. Clinical investigation

    Clinical investigation is measured by a neurosurgical method in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort

    Measured: Up to 1 year

  72. Oswestry disability index (ODI)

    ODI is measured in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort.

    Measured: Up to 1 year

  73. Back pain

    Low Back pain is measured by the Roland Morris Low Back pain and disability questionnaire in patients (PG, NFC, NO cohorts) with lumbal spine problems.

    Measured: Up to 1 year

  74. Leg pain

    Leg pain is measured by 100mm visual analog scale in patients (PG, NFC, NO cohorts) with lumbal spine problems.

    Measured: Up to 1 year

  75. Sciatica Bothersomeness Index

    To establish values for paresthesia, weakness and leg pain the Sciatica Bothersomeness Index is measured n patients (PG, NFC, NO cohorts) with lumbal spine problems.

    Measured: Up to 1 year

  76. Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

    To measure Disabilities of the Arm, Shoulder and Hand the DASH questionnaire is used in patient (PG, NFC, NO cohort) in patients with cervical spine problems

    Measured: Up to 1 year

  77. Modified Japanese orthopaedic association scale

    The modified Japanese Orthopaedic Association scale is used to establish criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy in patients (PG, NFC, NO cohorts) with cervical spine problems

    Measured: Up to 1 year

  78. ASIA Impairment Scale (AIS)

    ASIA Impairment Scale is used to measure for patients with spinal myelopathies or spinal cord injuries in patients from PG and NFC cohorts who undergo elective spine surgery and in control patients from NO cohort

    Measured: Up to 1 year

  79. Skill management

    Multiprofessional skill management is evaluated in all participating occupations of the GB cohort in qualitative interviews.

    Measured: Up to 1 year

  80. Acceptance of participatory decision-making

    Acceptance of participatory decision-making before and after participating in an SDM conference.

    Measured: Up to 1 year

  81. Depth of anesthesia

    Depth of anesthesia is measured by brainwaves in different patient states which range from awake, sedated, unresponsive, surgically anesthetized to deeply anesthetized.

    Measured: During surgery, an expected average of 2 hours

  82. Electroencephalography spectral analysis

    Electroencephalography spectral analysis is measured by brainwaves preoperatively.

    Measured: During the hospital stay, at the beginning of the investigation, an average of one hour.

  83. Electroencephalography band power

    Electroencephalography band power is measured postoperatively by an electroencephalography monitor at postoperative day 3 in all patients and in patients with delirium until 48 hours without positive delirium screening

    Measured: During the hospital stay, an expected average of 1 week

  84. Effect of analgesics

    Pain is evaluated with the Dolosys Paintracker. The Paintracker is a handy monitoring device to determine the analgesia needed for patients based on the pain reflex technique.

    Measured: During the hospital stay, an expected average of 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start19 May 2021
  3. Primary completion21 Mar 2025
  4. Study completion21 Mar 2025

Resources

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
693 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880824
Sponsor's protocol ID
ANA-PRAEP-GO
Status last verified
Aug 2025
First submitted
23 Apr 2021
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty Syndrome, run by Charite University, Berlin, Germany at 27 sites in Germany.

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 13 inclusion and 13 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 26 Aug 2025.

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