FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/083971 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 02/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Maintenance of body clock in patients with severe infection in icu 
Scientific Title of Study   Evaluation of a bundled intervention to restore circadian rhythm in critically ill sepsis patients- A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 5013, Teaching Block Department of Anaesthesiology, Pain Medicine & Critical Care
Ansari Nagar, All India Institute of Medical Sciences
South
DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 5013, Teaching Block Department of Anaesthesiology, Pain Medicine & Critical Care
Ansari Nagar, All India Institute of Medical Sciences

DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Public Query  
Name  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 5013, Teaching Block Department of Anaesthesiology, Pain Medicine & Critical Care
Ansari Nagar, All India Institute of Medical Sciences

DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Dr. Souvik Maitra 
Address  5013, Teaching Block, Department of Anaesthesiology, Pain Medicine & Critical Care All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029 
Type of Sponsor  Other [PI] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Souvik Maitra  All India Institute of Medical Sciences, New Delhi  Department of Anaesthesiology, Pain Medicine & Critical Care 8th Floor, Main Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029
South
DELHI 		 8146727891

souvikmaitra@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A498||Other bacterial infections of unspecified site, (2) ICD-10 Condition: A41||Other sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 2. Use of earplug in nighttime 3. Use of eye cover during nighttime 4. Avoidance of non- urgent procedures during the night 5. Early mobilization 6. Daytime (6.00 AM- 10.00 PM) restricted feeding schedule B. Pharmacological 1. Avoidance/ minimize the use of benzodiazepine and opioid particularly during night 2. Protocolized management of pain 3. Small dose of dexmedetomidine (0.2- 0.3 mcg/kg/hr) sedation during night The bundled care will be continued throughout the ICU stay Bundled intervention will be carried out through out the ICU stay  
Comparator Agent  Standard management of sepsis as per Surviving sepsis guidelines  broad spectrum antibiotics, fluid resuscitation, inotropic agents/ vasopressor and other supportive treatment as needed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult (aged between 18 and 75y), critically ill, patients with a diagnosis of sepsis as per Sepsis- 3 criteria. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rhythmicity of serum melatonin   At day 7 since randomisation 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 At post randomisation day 7 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 

 
Close