FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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.

 
Close