| 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
|
|
|
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
|
|
|
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
- 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 - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [anoushkachaudhary98@gmail.com].
- 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.
- 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 betweenâ€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 hypodynamicâ€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
Accordingâ€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 indicatorâ€of otherâ€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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