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Maintenance of body clock in patients with severe infection in icu

Evaluation of a bundled intervention to restore circadian rhythm in critically ill sepsis patients- A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/083971
Enrollment
150
Registered
2025-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A498- Other bacterial infections of unspecified site Health Condition 2: A41- Other sepsis

Interventions

Intervention1: Bundle of Care: Standard care for sepsis and the following bundeled care: A. Non- pharmacological 1. Minimization of ICU noise in nighttime by reducing the volume of monitor and alarms

Sponsors

Dr. Souvik Maitra
Lead Sponsor

Eligibility

Inclusion criteria

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: Exclusion Criteria: 1. Refusal to participate 2. Pregnancy or post- partum up to 6 weeks 3. Patients with history of known psychiatric illness 4. Patients with known history of sleep disturbance

Design outcomes

Primary

MeasureTime frame
Rhythmicity of serum melatoninTimepoint: At day 7 since randomisation—

Secondary

MeasureTime frame
Secondary objectives will be as follows: 1. To compare serum IL-1, Il-2, IL-6, IL-10 at day 7 post- randomization 2. To compare the ‘delirium free days’ during the ICU stay 3. To compare the duration of ICU stay and hospital stay 4. To compare 28- day and 90- day mortality Timepoint: At post randomisation day 7—

Countries

India

Contacts

Public ContactDr Souvik Maitra

All India Institute of Medical Sciences

souvikmaitra@live.com8146727891

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026