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CTRI Number  CTRI/2024/11/076432 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   EFFICACY OF A MULTI-COMPONENT CARE PLAN (ABCDEF BUNDLE) TO REDUCE CONFUSION IN CRITICALLY ILL ADULT PATIENTS WITH SEVERE INFECTIONS PRESENTED IN EMERGENCY DEPARTMENT 
Scientific Title of Study   EFFICACY OF ABCDEF BUNDLE (assess, prevent and manage pain, both spontaneous awakening and breathing trial, choice of analgesia and sedation, assess, prevent and manage delirium, early mobility and exercise, and family engagement and empowerment) FOR REDUCTION OF INTENSIVE CARE DELIRIUM IN ADULT EMERGENCY MEDICAL PATIENTS ADMITTED WITH SEPSIS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeeb Lama 
Designation  Junior resident, Internal medicine 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Room number 30 Block D Old Doctors Hostel PGIMER Sector 12 Chandigarh India
Sector 12, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India 
Phone  9548516085  
Fax    
Email  sanjeeblama69@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurabh C Sharda 
Designation  Assistant professor 
Affiliation  Postgraduate institute of medical education and research 
Address  Medicine office 4th floor Nehru hospital PGIMER sector 12 PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756670  
Fax    
Email  saurabhcsharda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saurabh C Sharda 
Designation  Assistant professor 
Affiliation  Postgraduate institute of medical education and research 
Address  Medicine office 4th floor Nehru hospital PGIMER sector 12 PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756670  
Fax    
Email  saurabhcsharda@gmail.com  
 
Source of Monetary or Material Support  
Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Sector 12, 160012 Chandigarh, India 
 
Primary Sponsor  
Name  Postgraduate institute of medical education and research 
Address  Postgraduate Institute of Medical Education and Research, Sector 12, 160012,Chandigarh India 
Type of Sponsor  Government medical college 
 
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 Sanjeeb Lama  Nehru Hospital, Postgraduate Institute of Medical Education and Research  Department of Internal Medicine, PGIMER, Sector 12, 160012,Chandigarh India
Chandigarh
CHANDIGARH 
9548516085

sanjeeblama69@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural), PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I959||Hypotension, unspecified, (2) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ABCDEF BUNDLE  Participants in this group will be applied ABCDEF bundle, i.e. 6 components viz Assess, prevent and manage pain, Both spontaneous awakening and breathing trials, Choice of analgesia and sedation, Assess, prevent and manage Delirium, Early mobility and exercise, and Family engagement and empowerment protocol within 24 hours of admission. Everyday, these 6 components of the ABCDEF bundle will be applied on them for a period of 14 days, and hence outcomes will be measured at the end of 14 consecutive days. 
Comparator Agent  Standard of care bundle  Participants in this group will receive conventional (standard) ICU care with decisions regarding the management of patient made by treating physician and no active intervention will be done in this group by the study team. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients ≥18 years of age presented with sepsis ( SOFA score≥2 for patient with no pre-existing organ dysfunction and acute change in SOFA score by ≥2 in a patient with pre-existing organ dysfunction) will be included in the study trial. 
 
ExclusionCriteria 
Details  Patients expected to have hospital stay less than 2 days of duration.
Patients who are unable to understand a common language due to visual, auditory or linguistic problems (unable to speak English, Hindi or Punjabi).
Patients who come under surgical unit.
Patients who come under trauma unit.
Patient who is pregnant.
Patient who has any evidence of meningitis or meningoencephalitis.
Patient who has any evidence of central nervous system disorder that is considered not to be caused by sepsis based on clinical examination e.g. Stroke, severe head trauma, brain tumour, cerebrovascular dementia and Alzheimer’s disease).
Patient denying for informed consent.
Patient who are COVID-19 RT-PCR positive.
Patients with drug intoxication.
Patients having withdrawal syndromes.
Patients diagnosed with envenomation.
Patients who are undergoing end of life care. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Incidence of delirium  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of delirium.
Length of stay in mechanical ventilation.
Length of stay in ICU.
Dose of antipsychotics.
Mortality. 
14 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   11/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjeeblama69@gmail.com].

  6. For how long will this data be available start date provided 05-12-2025 and end date provided 05-12-0020?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study will be carried out at the Emergency Medical Ward-22, Emergency department, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. The ABCDEF bundle will be used in daily care in this hospital’s 12 bed ICU, Emergency medical ward-22. The study population will comprise any adult (18-year or older) patients admitted to the hospital’s medical ICU with a diagnosis of sepsis or septic shock, independent of mechanical ventilator status. The pre-bundle (control) implementation group will have 30 patients, and the post-bundle (intervention) implementation group will have another 30 patients. Convenience sampling will be done. And for those who are eligible, proxy informed consent will be obtained from primary care taker, after omitting exclusion and will be taken for study. A registered nurse, junior resident on duty, and the lead investigator (junior resident) will be included in the process evaluation research team.

In the first 6 months, 30 patients will be enrolled in the trial as a control group. They will be assessed for sepsis using the Sequential Organ Failure Assessment (SOFA) scoring tool. 

Baseline SOFA score will be assumed to be zero in patients not known to have any pre-existing organ dysfunction and those with a score of 2 or above will be considered to have sepsis and eligible for study. In patients with pre-existing organ dysfunction, there should be acute change in total SOFA score by ≥ 2 points consequent to infection to be eligible. A patient will be considered to have an infection if the treating physician stated infection in the medical record or started antibiotics or there are serological (immunoglobulin titres) and/or microbiological evidence (body fluids positive for microbes with staining techniques or cultures) of infection. Patient meeting the criteria for sepsis with persisting hypotension requiring vasopressors to maintain MAP≥ 65 mmHg and having a serum lactate level >2 mmol/l (18mg/dl) despite adequate fluid resuscitation will be considered to be in septic shock.

Those who meet the inclusion and exclusion criteria, will be included in the study. Participants in this group will receive conventional (standard) ICU care with standard sepsis management algorithms and will be monitored for 14 days in the ICU or until discharged, death, or transfer to general ward or other departments, whichever occurs first. The junior resident (principal investigator) will keep the observation on pain management, SAT and SBT trials conducted on patients, assessment and management of delirium, degree of mobilization and the family engagement regarding the patients in this group but no intervention will be applied upon. If any subject develops delirium during their hospital stay, the duration of the delirium, antipsychotic dosages required, and length of ICU stay will all be noted. However, all decisions regarding the management of the patient will be made completely by the treating physician and in accordance with conventional ICU care, with no active intervention being used on this control group.

In the next 1 month, the residents and staffs on duty will be trained on implementing the ABCDEF bundle in ICU patients on a weekly basis for 4 consecutive weeks before implementation of the ABCDEF bundle.

Then another 30 patients will be enrolled in the same manner as before over the next 6 months. They will first be assessed for the presence of sepsis using the SOFA score, and if score of 2 or more achieved, with inclusion and exclusion criteria satisfied, they will be recruited in the trial. However, in this group, the ABCDEF bundle will be used from the start (within 24 hours after admission). Participants in this group will also be monitored for 14 days in the ICU or until discharged, death, or transfer to general ward or other departments, whichever occurs first.
Finally, the outcomes in the two groups will be analyzed to assess efficacy of the ABCDEF bundle in reducing intensive care delirium.

 
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