Investigating Nutrition and Functional Outcome in Critically Ill Patients

NCT04180852 | Completed

• 1 other identifier: 19-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurosurgical Patients; Elderly Patients; Obese Patients; Cardiac Surgery Patients; Abdominal Surgery Patients

Outcome Measures

Primary Outcomes (32)

• Nutritional status - basic demographics

  Chart review

  at Study inclusion

• Nutritional Status - nutritional screening

  Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)

  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

  ICU admission, up to 1 week

• Nutritional Status - Waist and mid-arm circumferences

  Waist and mid-arm circumferences

  Study inclusion, up to 1 week

• Differences of dosage of nutrition

  Cumulative delivery of macronutrients by infusion rates

  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

  until discharge from intensive care unit, an average of 30 days

• Differences of dosage of nutrition

  Cumulative delivery of macronutrients by nutrition used

  until discharge from intensive care unit, an average of 30 days

• Timing of nutrition

  Chart Review- start and stop times

  until discharge from intensive care unit, an average of 30 days

• Timing of nutrition - reason for discontinuation

  Chart review

  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

  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)

  discharge from intensive care unit, an average of 30 days

• Incidence Blood work irregularities

  Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)

  discharge from intensive care unit, an average of 30 days

• Incidence of Refeeding syndrome

  Chart review

  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)

  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

  discharge from intensive care unit, an average of 30 days

• Change in Muscle mass - Mid-arm circumference (MAC)

  MAC

  Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months

• Change in Muscle mass - Quadriceps thickness

  ultrasound

  Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months

• Change in Muscle mass - Quadriceps cross sectional area

  ultrasound

  Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months

• Change in Muscle strength - Handgrip strength

  Dynamometry

  discharge from intensive care unit and hospital discharge, up to 3 months

• Change in Muscle strength - Quadriceps strength

  Dynamometry

  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)

  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)

  discharge from intensive care unit and hospital discharge, up to 3 months

• Change in Physical function - 6-Minute Walk Test

  6-minute walking distance

  discharge from intensive care unit and hospital discharge, up to 3 months

• Change in Physical function - Manual Muscle Testing (MMT)

  MMT

  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)

  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)

  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)

  Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months

• Change in Fat mass

  Thigh and abdominal fat (ultrasound)

  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)

  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)

  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)

  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.

  day 30 after study inclusion

Secondary Outcomes (24)

• Mortality Rate

  up to 30 days after study inclusion

• Length of stay - intensive care unit length of stay

  discharge from intensive care unit, an average of 30 days

• Length of stay - Hospital length of stay

  Hospital discharge, an average of 60 days

• Readmission - ICU readmission rate

  Hospital discharge, day 30 after study inclusion, up to 3 months

• Readmission - Hospital readmission rate

  up to 30 days after study inclusion, up to 3 months

Study Arms (5)

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

Other: Functional tests without clinical consequence for the patients therapy

Elderly patients

Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years

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

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

Other: Functional tests without clinical consequence for the patients therapy

Abdominal surgical patients

Admission to the abdominal surgery ICU after abdominal surgery

Other: Functional tests without clinical consequence for the patients therapy

Interventions

Functional tests without clinical consequence for the patients therapy OTHER

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.

Abdominal surgical patients; Cardiac surgery patients; Elderly patients; Neurosurgical patients; Obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 29, 2019
• Study Start: January 4, 2019
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)