| 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 |
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Type of Study
|
Preventive |
| Study Design |
Other |
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Public Title of Study
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EFFICACY OF A MULTI-COMPONENT CARE PLAN (ABCDEF BUNDLE) TO REDUCE CONFUSION IN CRITICALLY ILL ADULT PATIENTS WITH SEVERE INFECTIONS PRESENTED IN EMERGENCY DEPARTMENT |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
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Source of Monetary or Material Support
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| Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Sector 12, 160012 Chandigarh, India |
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Primary Sponsor
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| 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 |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, (2) ICD-10 Condition: A419||Sepsis, unspecified organism, |
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Intervention / Comparator Agent
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| 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. |
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Inclusion Criteria
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| 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. |
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| 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. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| Outcome |
TimePoints |
| Incidence of delirium |
14 days |
|
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Secondary Outcome
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| Outcome |
TimePoints |
Duration of delirium.
Length of stay in mechanical ventilation.
Length of stay in ICU.
Dose of antipsychotics.
Mortality. |
14 days |
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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" |
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Phase of Trial
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N/A |
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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 |
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Estimated Duration of Trial
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Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sanjeeblama69@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
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Brief Summary
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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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