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CTRI Number  CTRI/2024/07/071610 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To determine the use of shock index on admission in predicting complications and death rates in secondary peritonitis  
Scientific Title of Study   Evaluation of shock index on admission as a predictor of mortality in secondary peritonitis  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anoushka Chaudhary 
Designation  PGJR 
Affiliation  Government medical college and hospital  
Address  Surgery office, D block, Level-III Government medical college and hospital, sec 32 Pin code-160030 Chandigarh India
Surgery office, D block, Level-III Government medical college and hospital, sec 32 Pin code-160030 Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  6283053483  
Fax    
Email  anoushkachaudhary98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Robin Kaushik  
Designation  Professor  
Affiliation  Government medical college and hospital, Chandigarh  
Address  Surgery department, Level-III, D block, Government medical college and hospital, Chandigarh 160031

Chandigarh
CHANDIGARH
160031
India 
Phone  9646121638  
Fax    
Email  robinkaushik@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Robin Kaushik  
Designation  Professor  
Affiliation  Government medical college and hospital, Chandigarh  
Address  Surgery department, Level-III, D block, Government medical college and hospital, Chandigarh 160031

Ambala
CHANDIGARH
160031
India 
Phone  9646121638  
Fax    
Email  robinkaushik@yahoo.com  
 
Source of Monetary or Material Support  
Government medical college and hospital, Chandigarh Pincode-160030 India Pincode-160030 
 
Primary Sponsor  
Name  Government medical college and hospital  
Address  Sector 32, Chandigarh Pincode-160030 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 Anoushka   Department of general surgery, D Block level-3, Government medical college and hospital   Sector 32 Pincode-160030 India
Chandigarh
CHANDIGARH 
6283052483

anoushkachaudhary98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patient willing for participation in the study.
All patients presenting in emergency with features of perforation peritonitis on clinical examination and radiological investigations.
 
 
ExclusionCriteria 
Details  1. Patients operated outside Government Medical College and Hospital, Chandigarh for secondary perforation peritonitis and being referred to our hospital for management of complications.
2. Cardiac patients or patients on antihypertensives.
3. Patients who were started on inotropic support within 2 hours of arrival in emergency.
4. Patients in immunocompromised state (HIV positive, patients on steroids or immunosuppressants)
5. Patients on Anticoagulants, Hypothyroid, Bronchial asthma, Autonomic dysfunction, CKD, Terminal illness, Addison’s crisis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To analyze the relationship between SI and mortality within the hospital stay of patients with secondary peritonitis.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. To analyze the relationship between SI & morbidity.
2. To analyze the relationship between MSI, mortality & morbidity.
3. To compare MSI & SI as a prognostic indicator of mortality. 
30 days  
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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)   08/08/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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 -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [anoushkachaudhary98@gmail.com].

  6. For how long will this data be available start date provided 03-07-2024 and end date provided 03-07-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

SI is an indicator of hemodynamic instability. It can be used to know the extent of circulatory collapse or non-hypovolemic shock and resuscitate accordingly, in all kinds of patients, despite the etiology. It is a good risk stratification method to guide resuscitative measures and predict early mortality. SI is a useful tool that can alert one to abnormalities even when the patient is vitally stable due to compensation by body.11,12 When compared to blood pressure and heart rate alone, it is a more accurate predictor of outcome in patients with illnesses such pulmonary embolism who are not in shock.13

Patients with acute circulatory failure have been found to have considerably worse outcomes when their SI is above 1.0.14

Compared to pulse or blood pressure alone, a SI ≥ 0.9 indicated urgency in triaging, higher hospital admission rates, and extensive therapy upon admission. This study suggested that SI might be an effective method for identifying and assessing critical illness in the emergency early on.11

In order to determine how well the SI can predict the primary outcome of 28-day mortality and the secondary outcome of hyperlactatemia, which acts as a proxy for the severity of the condition, an observational cohort study was conducted by Berger T et al. If a patient’s SI was 0.7 or greater, three times as many participants as those with a normal SI, were predicted to present with hyperlactatemia. The best predictor of both outcomes was SI ≥ 1.0.15

A retrospective observational study of 50 patients in 2010 showed that SI at 1 hour has low specificity (45.8%) as a predictor of mortality in ED patients with septic shock, but it has a high sensitivity (73.1%). SI at 2 hours has a sensitivity of 80.8% and a specificity of 79.2% for death at a cut-off point of > 1.0. This demonstrates that SI at 2 hours is far more accurate than SI at 1 hour as an early predictor of death in patients with septic shock.16

A one-year cross-sectional study conducted in 2015 included patients with hypotension and septicemia. MAP, SI, and MSI were calculated and requirement of vasopressors was assessed. The greatest sensitivity and specificity were found to be associated with a cut-off SI value of 0.87 or above for predicting how adequately the patient would respond to initial fluid resuscitation given. 17

Liu YC et al showed that a critically ill patient’s DBP would drop sooner than their SBP, so MAP is a more reliable indicator of the severity of their illness.18 Studies have shown linear inverse relationship between”parameters such as cardiac index, stroke volume, left ventricular stroke work, MAP and SI.14 MSI is inversely related to Stroke volume and systemic vascular resistance which means a low MSI is suggestive of a hyperdynamic circulation whereas a high MSI is suggestive of a hypodynamic”circulation.14

A retrospective study from 2009 showed that MSI greater that 1.3 is indicative of higher chances of ICU stay and mortality. MSI >1.3 and <0.7 was a stronger predictor of mortality than SI.18

According”to a retrospective cohort from January 2016 to December 2017, SI ≥1.0 and MSI ≥1.3 were both specific for sepsis prediction In terms of accuracy MSI was better than SI. MSI≥ 1.0 was the most sensitive predictor of mortality (positive predictive value-97.8% and specificity-76.2%) whereas MSI of ≥1.3 was better at predicting sepsis, ICU stay, hyperlactemia and one month mortality. MSI>1.0 was associated with five times higher risk of ICU admissions and death. Sepsis and hyperlactatemia were linked to a SI of ≥1.0, but not ICU admission or death.“When it came to predicting sepsis, a SI of ≥ 0.7 was less sensitive than an MSI of ≥ 1.0 and was not a reliable indicator”of other”outcomes.19

As laboratory tests, various scoring systems and radiological investigations are cumbersome. MSI and SI are very easy to comprehend and non-invasive in nature, which makes them an attractive candidate for early detection of conditions associated with hemodynamic instability even at PHC level. It’s potential use as a prognostic marker in secondary peritonitis may offer a new avenue for early intervention but due to lack of studies it requires further investigation. This research study aims to conduct a comprehensive analysis of existing literature and compare MSI and SI as a predictor of mortality and morbidity, establish a relationship between them, evaluate them as an individual predictor and assess which one is a superior predictor of mortality. 


 
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