The effect of supplemental ketone drinks in patients with brain injury on improve long term outcomes: A feasibility study

Not Applicable

• Conditions: subarachnoid haemorrhage; brain injury; intracerebral haemorrhage; Neurological - Other neurological disorders; Stroke - Haemorrhagic

• Registration Number: ACTRN12624001007527
• Lead Sponsor: Sir Charles Gairdner Hospital, Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Any patient, intubated and mechanically ventilated with a nasogastric tube, within 8 hours of admission who is anticipated to survive at least 72 hours with the following:

1. Patients with subarachnoid haemorrhage with an admission Glasgow Coma Scale (GCS) less than or equal to 8

2. Patients admitted following out of hospital cardiac arrest who are intubated with a GCS less than or equal to 8

Exclusion Criteria

1. Age < 18 years old
2. Pregnant
3. Suffering from Acute or Chronic liver disease
4. Type 1 diabetes mellitus
5. Treating clinician determines that the administration of ketone esters is inappropriate for the patient
6. Base of skull fracture precluding insertion of nasogastric tube (NGT)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility[The primary outcome will be study feasibility. The study will be deemed feasible if all of the following criteria are met:<br>1.Less than or equal to 50% of patients (or their proxies) refuse to participate on the basis of concerns over ketone administration<br>2.Greater than or equal to 80% of patients randomised to ketone ester supplementation receive them within the first eight hours of ICU admission<br><br>Data gathered for assessment of these measures will be documented on a secure server on a computer within the research department of the ICU, after transcription from the study report form. These will be recorded on RedCap software. Upon conclusion of study]