| CTRI Number |
CTRI/2018/02/011718 [Registered on: 05/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
can blood measurement and ratio between c reactive protein and albumin before operation predict need of mechanical ventilation after operation in those patients undergoing operation other than heart surgery |
|
Scientific Title of Study
|
Preoperative c reactive protein albumin ratio as a predictor of postoperative mechanical ventilation in patients undergoing non-cardiac surgery under general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/AIIMS BBSR/PG Thesis/2017-18/30 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishakh Tharavath |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences |
| Address |
Room No. 601
PG 2 Hostel
AIIMS Accomodation campus
Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
|
| Fax |
|
| Email |
vaishakh4154@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vaishakh Tharavath |
| Designation |
student |
| Affiliation |
All india institute of medical sciences |
| Address |
Room no 427
Fourth floor,
Academic building,
All india institute of medical sciences,
sijua,
Patrapada,
Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
|
| Fax |
|
| Email |
sukdev.nayak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vaishakh Tharavath |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences |
| Address |
Room No. 601
PG 2 Hostel
AIIMS Accomodation campus
Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
|
| Fax |
|
| Email |
vaishakh4154@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences
Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences |
| Address |
Sijua
Patrapada
Bhubaneswar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Regional medical research centre |
Bhubaneswar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaishakh Tharavath |
All india institute of medical sciences |
Department of anaesthesia,
Trauma block
Ground floor
AIIMS hospital
Bhubaneswar Khordha ORISSA |
7736767667
vaishakh4154@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, those undergoing surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective and emergency surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
those patients who are on mechanical ventilation before surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| need for mechanical ventilation in the postoperative period |
till hospital discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative need for vasopressors, amount of blood loss |
intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="1650" Sample Size from India="1650"
Final Enrollment numbers achieved (Total)= "590"
Final Enrollment numbers achieved (India)="590" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2018 |
| Date of Study Completion (India) |
26/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Guo S, He X, Chen Q, et al. The C-reactive protein/albumin ratio, a validated prognostic score, predicts outcome of surgical renal cell carcinoma patients. BMC Cancer. 2017;17:171.
2. Tao C-J, Chen Y-Y, Jiang F, et al. The C-reactive Protein/Albumin Ratio Is an independent Prognostic Factor for Overall Survival in Patients with Nasopharyngeal Carcinoma Receiving Intensity-Modulated Radiotherapy. Journal of Cancer. 2016;7(14):2005-2011.
3. Zhou T, Zhan J, Hong S, et al. Ratio of C-Reactive Protein/Albumin is An Inflammatory Prognostic Score for Predicting Overall Survival of Patients with Small-cell Lung Cancer. Scientific Reports. 2015;5:10481.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In
the current context, mechanical ventilation and ICU beds are limited
but essential resources. Mechanical ventilation in the
post-operative period adds to the morbidity
and mortality of surgical patients and incurs extra
stress on the patient, family and economic burden on the hospital.
Hence, pre-operative prediction contributes to adequate optimisation
and effective utilisation. But,
unfortunately, the literature only provides us with predictors for
mechanical ventilation in a very limited set of patients. Therefore,
we experience a limitation in pre-operative optimisation, patient and
family counselling and appropriate distribution of available
resources.
Peri-operative
inflammation is a state of high demand. Low albumin is a sign of poor
nutritional status. Additionally, serum albumin being a negative
acute phase reactant, the level is usually low in patients with
heightened inflammation. CRP being a positive acute phase reactant,
its level is usually raised in cases of any inflammation or any
infections. So, the CRP/Albumin ratio gives us a combined health
status of a patient. Further, CRP/Albumin ratio has been widely
proven as a prognostic indicator and mortality predictor in patients
with various malignancies and severe sepsis.
We,
therefore hypothesise that patients with high pre-operative
CRP/Albumin ratio will require mechanical ventilation
post-operatively.
|