Evaluation of a bundled intervention to restore circadian rhythm in critically ill sepsis patients- A randomized controlled trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Rhythmicity of serum melatonin
Study Overview
Brief Summary
In this randomized controlled study, n=150 critically ill adult patients with a diagnosis of ‘sepsis’ as per Sepsis- 3 criterial will be recruited. Eligible patients will be randomized to either group B (bundled care to preserve circadian rhythm) and group S (standard of care). ‘Bundled care’ will included Zeitgeber optimization, protocolized pain control, low dose night time dexmedetomidine, postponing non- urgent care to daytime, minimization of night time light and sound exposure. All patients will be followed daily, for development of ICU acquired delirium, organ dysfunction and requirement of other organ support. Blood samples will be obtained four times daily (3.00 AM, 6.00 AM, 2.00 PM and 8.00 PM) for first two days of ICU stay (day 1, & 2) and similarly on day 6 and 7.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult (aged between 18 and 75y), critically ill, patients with a diagnosis of sepsis as per Sepsis- 3 criteria.
Exclusion Criteria
- •Exclusion Criteria:
- •Refusal to participate
- •Pregnancy or post- partum up to 6 weeks
- •Patients with history of known psychiatric illness
- •Patients with known history of sleep disturbance.
Outcomes
Primary Outcomes
Rhythmicity of serum melatonin
Time Frame: At day 7 since randomisation
Secondary Outcomes
- Secondary objectives will be as follows:(1. To compare serum IL-1, Il-2, IL-6, IL-10 at day 7 post- randomization)
Investigators
Dr Souvik Maitra
All India Institute of Medical Sciences