| CTRI Number |
CTRI/2024/10/075247 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observation Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the incidence and risk factors for delirium( mental state where the person is confused, disoriented, and not able to think or remember clearly) in operated patients receiving renal transplant |
|
Scientific Title of Study
|
Incidence And Risk Factors For Post Operative Delirium In Renal Transplant Recipients: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalrammuani |
| Designation |
Junior Resident Doctor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia, Nehru Block
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9366574420 |
| Fax |
|
| Email |
lalrammuani2421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Naik B |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia, Nehru Hospital
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872377925 |
| Fax |
|
| Email |
navin_amc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lalrammuani |
| Designation |
Junior Resident Doctor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia, Nehru Block
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9366574420 |
| Fax |
|
| Email |
lalrammuani2421@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Nehru Block
Post Graduate Institute of Medical Education and Research,
Sector 12, Chandigarh
Pincode- 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesiology
Post Graduate Institute of Medical Education and Research
Chandigarh, Pincode 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lalrammuani |
PGIMER |
Department of Anaesthesia and Intensive care, Nehru hospital, A-Block
Chandigarh
CHANDIGARH |
9366574420
Lalrammuani2421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research,Chandigarh, Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient age from 18 to 60 years both male and female with informed consent obtained from them |
|
| ExclusionCriteria |
| Details |
1. Pre- existing cognitive dysfunction or dementia
2. On mechanical ventilation post-operatively in ICU
3. Incomplete data |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence 0f Post Operative Delirium during the first 24 hours post extubation (POD defined as a single event of positive CAM ICU, assessed every 2 hour post extubation ) |
First 24 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of Post operative delirium at any time point in ICU stay assessed 12hourly until discharge from ICU
2. Risk factors of interest: Preoperative, intraoperative and postoperative
3. Any adverse events after delirium (re-intubation, aspiration, functional limitation or electrolyte imbalance) |
from Post extubation to till discharge of the patient |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
21/10/2024 |
| 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)
|
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
|
Delirium is the acute decline and fluctuation in cognitive function following surgery and is common among kidney transplant recipients of all ages.It is frequently unrecognized and underdiagnosed and manifestation is often variable and inconsistent. Delirium is associated with adverse outcomes such as- extended hospitalization, delayed graft function,graft loss, increased morbidity and mortality.It has multifactorial etiologies complex mix of predisposing recipients, donor, transplant factor,as well as intra-operative and perioperative factors.Information of the incidence and risk factors for post-operative delirium in renal transplant s scare.The primary Aim: To establish the incidence and identify the risk factors of post-operative delirium in patients undergoing renal transplant surgery under general anesthesia |