Neurosurgical PatientsINFONCT04180852
Investigating Nutrition and Functional Outcome in Critically Ill Patients
An observational study of Neurosurgical Patients and Elderly Patients, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgical Patients, Elderly Patients, Obese Patients
- What is being tested?
- Functional tests without clinical consequence for the patients therapy
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jan 2019to 4 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a clinical trial, which will include critically ill patients after informed consent. Patients who admitted to a surgical ICU following surgery or requiring surgery can be screened and included by our team. The general eligibility criteria are listed above. We will recruit patients, who can be classified as one of the following groups: a) neurosurgical Patients, b) elderly patients, c) obese patients, d) cardiac surgery patients and e) abdominal surgery patients
Who may be able to join
- Informed consent
- Adult patients (≥ 18 years)
- Patients admitted to a surgical ICU requiring surgical Intervention
- Patients requiring sedation and invasive ventilation for ≥ 48 hours
- Patients with an expected ICU-length of stay ≥ 72 hours
Who cannot join
- Pregnant or lactating patients
- Patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission
- Patients with disabling disease (neurological or physical) that prevents them from walking, sitting or standing before ICU admission
- Patients unable to follow orders from the study personnel (language barriers, neurological, psychiatric disorders)
- Death expected within 96 hours after admission due to severity of disease
- Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.
Read the detailed description
The investigators propose a prospective observational, single-center, multi-intensive care unit trial to evaluate the influence of current nutritional practice on the physical outcome in critically ill patients. At least 100 consecutive patients requiring surgery, who are admitted to any surgical ICU at the University Hospital RWTH Aachen will be recruited. Nutritional practices, such as dosage, timing and route of administration of the nutrition, as well as complications regarding the nutrition will be recorded and analyzed longitudinally from ICU-admission until hospital discharge. Patient outcomes, such as ICU- and hospital length of stay, duration of mechanical ventilation, organ dysfunction, complications and infections will be evaluated. To assess physical function of the patient, muscle mass, muscle strength, the ability of the patient to self-mobilize and perform every day activities will be measured.
This observational trial aims to assess the current standard of nutritional practice in the ICU, to detect problems and complications and to gather first evidences about the influence of nutrition on the physical function of the patient. This study also aims to compare the outcome of the predefined subgroups of critically ill patients.
- Conditions
- Neurosurgical Patients, Elderly Patients, Obese Patients, Cardiac Surgery Patients, Abdominal Surgery Patients
- Being tested
- Functional tests without clinical consequence for the patients therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional tests without clinical consequence for the patients therapyOther
Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Neurosurgical patients | Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups:
1. Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage)
2. Acute and severe head trauma with an initial Glasgow Coma Scale ≤10 Receives: Other: Functional tests without clinical consequence for the patients therapy | |
| Elderly patients | Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years Receives: Other: Functional tests without clinical consequence for the patients therapy | |
| Obese patients | BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2 Receives: Other: Functional tests without clinical consequence for the patients therapy | |
| Cardiac surgery patients | Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups:
1. Coronary revascularization (coronary artery bypass graft)
2. Heart valve surgery
3. Combined or complex heart surgery Receives: Other: Functional tests without clinical consequence for the patients therapy | |
| Abdominal surgical patients | Admission to the abdominal surgery ICU after abdominal surgery Receives: Other: Functional tests without clinical consequence for the patients therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status - basic demographics
Chart review
Measured: at Study inclusion
Nutritional Status - nutritional screening
Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)
Measured: intensive care unit (ICU) admission, up to 1 week
Nutritional Status - nutritional risk in the critically ill (NUTRIC)
NUTRIC score (Score 0-10; if interleucin-6 (IL6) available 0-5=low malnutrition risk; if IL6 not available 0-4= at low malnutrition risk
Measured: ICU admission, up to 1 week
Nutritional Status - Waist and mid-arm circumferences
Waist and mid-arm circumferences
Measured: Study inclusion, up to 1 week
Differences of dosage of nutrition
Cumulative delivery of macronutrients by infusion rates
Measured: until discharge from intensive care unit, an average of 30 days
Differences of dosage of nutrition
Cumulative delivery of macronutrients by cumulative count of macronutrients
Measured: until discharge from intensive care unit, an average of 30 days
Differences of dosage of nutrition
Cumulative delivery of macronutrients by nutrition used
Measured: until discharge from intensive care unit, an average of 30 days
Timing of nutrition
Chart Review- start and stop times
Measured: until discharge from intensive care unit, an average of 30 days
Timing of nutrition - reason for discontinuation
Chart review
Measured: at discharge from intensive care unit, an average of 30 days
Differences in route of administration of nutrition
Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition
Measured: discharge from intensive care unit, an average of 30 days
Incidence of Gastrointestinal symptoms
Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)
Measured: discharge from intensive care unit, an average of 30 days
Incidence Blood work irregularities
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
Measured: discharge from intensive care unit, an average of 30 days
Incidence of Refeeding syndrome
Chart review
Measured: discharge from intensive care unit, an average of 30 days
Incidence of complications related to the route of administration
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
Measured: discharge from intensive care unit, an average of 30 days
Nutrition adequacy
Rates of energy and protein received in comparison to nutritional targets Chart review
Measured: discharge from intensive care unit, an average of 30 days
Change in Muscle mass - Mid-arm circumference (MAC)
MAC
Measured: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle mass - Quadriceps thickness
ultrasound
Measured: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle mass - Quadriceps cross sectional area
ultrasound
Measured: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle strength - Handgrip strength
Dynamometry
Measured: discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle strength - Quadriceps strength
Dynamometry
Measured: discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Functional Status Score for the ICU
Functional Status Score for Intensive Care Unit (FSS-ICU) (Score 0-35; the higher the score, the better physical functioning)
Measured: discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Short Physical Performance Battery
Short Physical Performance Battery (SPPB) (Score: 0-12; 0=worst performance and 12=best performance)
Measured: discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - 6-Minute Walk Test
6-minute walking distance
Measured: discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Manual Muscle Testing (MMT)
MMT
Measured: discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Katz Activities of Daily Living (ADL)
ADL (Score: 0-100; the higher the more independent)
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)
IADL (score 0-8; the higher the more independent)
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Physical function - Clinical Frailty Score (CFS)
CFS (score 1-9; 1= Very fit and 9=terminally ill)
Measured: Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Fat mass
Thigh and abdominal fat (ultrasound)
Measured: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Neuro-psychological function - Mini Mental State Examination (MMSE)
MMSE (Score 0-30; 30= no dementia and <9= severe dementia)
Measured: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Neuro-psychological function - Becks Depression Inventory (BDI)
BDI (Score 0-63; 0= no depression and 63= severe depression)
Measured: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
Quality of life - Short Form 36 (SF-36)
SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
Measured: day 30 after study inclusion
Quality of life - Living location
Rates of patients being discharged to nursing home, rehabilitation, home care etc. Discharge location used as surrogate for physical fitness after hospital discharge.
Measured: day 30 after study inclusion
Secondary outcomes (24)
Mortality Rate
Mortality
Measured: up to 30 days after study inclusion
Length of stay - intensive care unit length of stay
ICU length of stay
Measured: discharge from intensive care unit, an average of 30 days
Length of stay - Hospital length of stay
Hospital length of stay
Measured: Hospital discharge, an average of 60 days
Readmission - ICU readmission rate
ICU readmission rate
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Readmission - Hospital readmission rate
Hospital readmission rate
Measured: up to 30 days after study inclusion, up to 3 months
Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
daily records (score 0-24; 0=normal function and 24= massively impaired function)
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters
blood pressure in mmHg
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters
vasopressors, cumulative dosage in ml/d
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters
heart rate bpm
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - incidence of ventilation
mode of ventilation
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - duration of ventilation
hours of ventilation
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - sedation
duration of sedation in hours
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - sedation
dosage of sedation, cumulative dosage in ml/d
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - Richmond Agitation Scale
Richmond Agitation Scale (score: +4 - -5; +4=aggressive behavior, 0=calm,-5=not reacting to verbal or physical approaches)
Measured: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)
CAM-ICU (score: 0-10; more than 2 errors= delirium)
Measured: up to discharge from intensive care unit, an average of 30 days
Persistent Organ Dysfunction - Incidence of mechanical ventilation
need for ventilation
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Persistent Organ Dysfunction - Incidence of hemodynamic parameters
vasopressors
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Persistent Organ Dysfunction - Incidence of renal replacement therapy
renal replacement therapy
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of surgical reevaluation
surgical reevaluation
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of hemorrhage
hemorrhage
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of thromboembolic events
thromboembolic events
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of cardiovascular events
cardiovascular events
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of infection
infection
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of sepsis
sepsis
Measured: Hospital discharge, day 30 after study inclusion, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start4 Jan 2019
- Primary completion4 May 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgical PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Stoppe, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180852
- Sponsor's protocol ID
- 19-001
- Acronym
- INFO
- Status last verified
- May 2022
- First submitted
- 7 Nov 2019
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Nutrition and Functional Outcome in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04180852
- Acronym / sponsor ID
- INFO / 19-001
- Conditions
- Neurosurgical Patients, Elderly Patients, Obese Patients, Cardiac Surgery Patients, Abdominal Surgery Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.
Detailed description
The investigators propose a prospective observational, single-center, multi-intensive care unit trial to evaluate the influence of current nutritional practice on the physical outcome in critically ill patients. At least 100 consecutive patients requiring surgery, who are admitted to any surgical ICU at the University Hospital RWTH Aachen will be recruited. Nutritional practices, such as dosage, timing and route of administration of the nutrition, as well as complications regarding the nutrition will be recorded and analyzed longitudinally from ICU-admission until hospital discharge. Patient outcomes, such as ICU- and hospital length of stay, duration of mechanical ventilation, organ dysfunction, complications and infections will be evaluated. To assess physical function of the patient, muscle mass, muscle strength, the ability of the patient to self-mobilize and perform every day activities will be measured.
This observational trial aims to assess the current standard of nutritional practice in the ICU, to detect problems and complications and to gather first evidences about the influence of nutrition on the physical function of the patient. This study also aims to compare the outcome of the predefined subgroups of critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Neurosurgical patients | – | Other: Functional tests without clinical consequence for the patients therapyNon-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups: 1. Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage) 2. Acute and severe head trauma with an initial Glasgow Coma Scale ≤10 |
| Elderly patients | – | Other: Functional tests without clinical consequence for the patients therapyAge ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years |
| Obese patients | – | Other: Functional tests without clinical consequence for the patients therapyBMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2 |
| Cardiac surgery patients | – | Other: Functional tests without clinical consequence for the patients therapyAdmission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups: 1. Coronary revascularization (coronary artery bypass graft) 2. Heart valve surgery 3. Combined or complex heart surgery |
| Abdominal surgical patients | – | Other: Functional tests without clinical consequence for the patients therapyAdmission to the abdominal surgery ICU after abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a clinical trial, which will include critically ill patients after informed consent. Patients who admitted to a surgical ICU following surgery or requiring surgery can be screened and included by our team. The general eligibility criteria are listed above. We will recruit patients, who can be classified as one of the following groups: a) neurosurgical Patients, b) elderly patients, c) obese patients, d) cardiac surgery patients and e) abdominal surgery patients
Key inclusion criteria (5 listed)
- Informed consent
- Adult patients (≥ 18 years)
- Patients admitted to a surgical ICU requiring surgical Intervention
- Patients requiring sedation and invasive ventilation for ≥ 48 hours
- Patients with an expected ICU-length of stay ≥ 72 hours
Key exclusion criteria (6 listed)
- Pregnant or lactating patients
- Patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission
- Patients with disabling disease (neurological or physical) that prevents them from walking, sitting or standing before ICU admission
- Patients unable to follow orders from the study personnel (language barriers, neurological, psychiatric disorders)
- Death expected within 96 hours after admission due to severity of disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional tests without clinical consequence for the patients therapyBattery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life. | Other | Abdominal surgical patients, Cardiac surgery patients, Elderly patients, Neurosurgical patients, Obese patients |
Primary outcome
Nutritional status - basic demographics
Time frame: at Study inclusion
Chart review
Nutritional Status - nutritional screening
Time frame: intensive care unit (ICU) admission, up to 1 week
Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)
Nutritional Status - nutritional risk in the critically ill (NUTRIC)
Time frame: ICU admission, up to 1 week
NUTRIC score (Score 0-10; if interleucin-6 (IL6) available 0-5=low malnutrition risk; if IL6 not available 0-4= at low malnutrition risk
Nutritional Status - Waist and mid-arm circumferences
Time frame: Study inclusion, up to 1 week
Waist and mid-arm circumferences
Differences of dosage of nutrition
Time frame: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by infusion rates
Differences of dosage of nutrition
Time frame: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by cumulative count of macronutrients
Differences of dosage of nutrition
Time frame: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by nutrition used
Timing of nutrition
Time frame: until discharge from intensive care unit, an average of 30 days
Chart Review- start and stop times
Timing of nutrition - reason for discontinuation
Time frame: at discharge from intensive care unit, an average of 30 days
Chart review
Differences in route of administration of nutrition
Time frame: discharge from intensive care unit, an average of 30 days
Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition
Incidence of Gastrointestinal symptoms
Time frame: discharge from intensive care unit, an average of 30 days
Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)
Incidence Blood work irregularities
Time frame: discharge from intensive care unit, an average of 30 days
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
Incidence of Refeeding syndrome
Time frame: discharge from intensive care unit, an average of 30 days
Chart review
Incidence of complications related to the route of administration
Time frame: discharge from intensive care unit, an average of 30 days
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
Nutrition adequacy
Time frame: discharge from intensive care unit, an average of 30 days
Rates of energy and protein received in comparison to nutritional targets Chart review
Change in Muscle mass - Mid-arm circumference (MAC)
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
MAC
Change in Muscle mass - Quadriceps thickness
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
ultrasound
Change in Muscle mass - Quadriceps cross sectional area
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
ultrasound
Change in Muscle strength - Handgrip strength
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
Dynamometry
Change in Muscle strength - Quadriceps strength
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
Dynamometry
Change in Physical function - Functional Status Score for the ICU
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
Functional Status Score for Intensive Care Unit (FSS-ICU) (Score 0-35; the higher the score, the better physical functioning)
Change in Physical function - Short Physical Performance Battery
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
Short Physical Performance Battery (SPPB) (Score: 0-12; 0=worst performance and 12=best performance)
Change in Physical function - 6-Minute Walk Test
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
6-minute walking distance
Change in Physical function - Manual Muscle Testing (MMT)
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
MMT
Change in Physical function - Katz Activities of Daily Living (ADL)
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
ADL (Score: 0-100; the higher the more independent)
Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
IADL (score 0-8; the higher the more independent)
Change in Physical function - Clinical Frailty Score (CFS)
Time frame: Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
CFS (score 1-9; 1= Very fit and 9=terminally ill)
Change in Fat mass
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Thigh and abdominal fat (ultrasound)
Change in Neuro-psychological function - Mini Mental State Examination (MMSE)
Time frame: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
MMSE (Score 0-30; 30= no dementia and <9= severe dementia)
Change in Neuro-psychological function - Becks Depression Inventory (BDI)
Time frame: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
BDI (Score 0-63; 0= no depression and 63= severe depression)
Quality of life - Short Form 36 (SF-36)
Time frame: day 30 after study inclusion
SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
Quality of life - Living location
Time frame: day 30 after study inclusion
Rates of patients being discharged to nursing home, rehabilitation, home care etc. Discharge location used as surrogate for physical fitness after hospital discharge.
24 secondary outcomes
Mortality Rate
Time frame: up to 30 days after study inclusion
Length of stay - intensive care unit length of stay
Time frame: discharge from intensive care unit, an average of 30 days
Length of stay - Hospital length of stay
Time frame: Hospital discharge, an average of 60 days
Readmission - ICU readmission rate
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Readmission - Hospital readmission rate
Time frame: up to 30 days after study inclusion, up to 3 months
Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - incidence of ventilation
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - duration of ventilation
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - sedation
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - sedation
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - Richmond Agitation Scale
Time frame: up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: up to discharge from intensive care unit, an average of 30 days
Persistent Organ Dysfunction - Incidence of mechanical ventilation
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Persistent Organ Dysfunction - Incidence of hemodynamic parameters
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Persistent Organ Dysfunction - Incidence of renal replacement therapy
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of surgical reevaluation
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of hemorrhage
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of thromboembolic events
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of cardiovascular events
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of infection
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of sepsis
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgical Patients and Elderly Patients, run by RWTH Aachen University at 1 site 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 5 inclusion and 6 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Nutritional status - basic demographics (time frame: at Study inclusion). The study lists 32 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 May 2022.