REINSTATE trial: Resolution of Elements Influencing Nutritional STatus After criTical illnEss

Not Applicable

Completed

• Conditions: Critical illness; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618000370202
• Lead Sponsor: Dr Lee-anne Chapple

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Study Completion: 2020-02-13
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Critically ill patients:
Patients admitted to the Royal Adelaide Hospital Intensive Care Unit (ICU) from March 2018 will be assessed for eligibility. Thirty eligible patients will be recruited (accounting for drop-outs to reach the target of 20 patients).

- Aged greater than or equal to 18 years of age
- Receiving invasive mechanical ventilation
- Planned to receive enteral nutrition
- Patients expected to remain ventilated for greater than 48 hours and stay in ICU for greater than 72 hours
- Feed intolerant (defined as at least one gastric residual volume of greater than or equal to 250 mL in the 24 hrs preceding enrolment, or if gastrokinetic drugs were already prescribed to the patient on the basis of gastric residual volume of greater than or equal to 250 mL)

Healthy participants:
Data will be compared with that from 10 age, sex, and BMI-matched healthy participants. Healthy participants will be recruited by advertisement within the Royal Adelaide Hospital.

Exclusion Criteria

Critically ill patients:

- Patients expected to be unable to follow commands and give informed consent after extubation (i.e. head injured, subarachnoid haemorrhage and history of dementia)
- Gastrointestinal surgery on this admission
- Previous upper gastrointestinal surgery (oesophageal, stomach or duodenal)
- Unable to obtain informed consent
- Lives greater than 50km from Adelaide (therefore unable to return for 3 month study day)
- Patient’s next of kin believe the patient will not be willing to have study measurements completed on hospital ward after ICU discharge and also return to the hospital for follow up at 3 months.
- Likely not survive ICU
- Haemoglobin <80g/L

Healthy participants:

- Inability to give informed consent
- Pregnant or breastfeeding
- Previous gestational diabetes
- Acute or chronic pancreatitis
- Medications known to affect glucose metabolism (e.g. steroids) or gastrointestinal motility (e.g. prokinetics, antidepressants, sedatives, opiates, anticonvulsant agents)
- Previous gastrointestinal surgery (apart from appendectomy)
- Current or previous gastrointestinal disease or major dysfunction
- Regular consumption >20 g alcohol or >10 cigarettes per day

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric emptying using (13)C-octanoate isotope breath test [ 4 hours post-test meal (1) during mechanical ventilation in ICU; (2) on the hospital ward within 7 days of discharge from ICU; (3) 3 months after ICU admission<br><br>Breath samples will be collected at baseline and 5 minutely for the first hour and subsequently every 15 minutes for the remaining 3 hours to measure 13Co2 concentrations. Area under the concentration curve for the four hours of measurements will be used to calculate the gastric emptying coefficient (GEC), a global index of the gastric emptying rate, with a higher number indicating faster emptying.]