FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057952 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Observational Study on Serum Calcium and Serum Lactate Ratio in Acute Pancreatitis for predicting Severity, Clinical outcome and Hospital stay duration at KLES Prabhakar Kore Hospital. 
Scientific Title of Study   Prospective Observational Study on Serum Calcium and Serum Lactate Ratio in Acute Pancreatitis for predicting Severity, Clinical outcome and Hospital stay duration at KLES Prabhakar Kore Hospital. 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ekta Bharadia 
Designation  Postgraduate student 
Affiliation  KLES Dr.Prabhakar Kore Hospital,Belagavi 
Address  Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8247339679  
Fax    
Email  b.ektaa888@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vishwanath Mallappa Pattanshetti 
Designation  Vice-Principal and Professor 
Affiliation  KLES Dr.Prabhakar Kore Hospital, Belagavi 
Address  Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  09886175471  
Fax    
Email  drvmshetti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ekta Bharadia 
Designation  Postgraduate student 
Affiliation  KLES Dr.Prabhakar Kore Hospital,Belagavi 
Address  Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka
Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  8247339679  
Fax    
Email  b.ektaa888@gmail.com  
 
Source of Monetary or Material Support  
KLES Prabhakar Kore Hospital,Nehru Nagar, Belagavi,Karnataka, 590010 
 
Primary Sponsor  
Name  KLES Prabhakar Kore Hospital 
Address  KLES Dr.Prabhakar Kore Hospital,Nehru Nagar,Belagavi.  
Type of Sponsor  Private 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 
DrEkta Bharadia  KLES DR.PRABHAKAR KORE HOSPITAL  General Surgery Department. OPD no.4
Belgaum
KARNATAKA 
8247339679

b.ekta888@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NILL  NILL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to give consent, of either sex, of age group 21-60 years and diagnosed as acute pancreatitis.
The diagnosis of Acute Pancreatitis should include two of the following three features:
1.Upper Abdominal pain of acute onset often radiating to back.
2.Serum amylase or lipase activity greater than 3 times normal, and
3. findings on cross sectional abdominal imaging consistent with acute pancreatitis 
 
ExclusionCriteria 
Details  1. Age< 21 years,
2. Pregnant and lactating females,
3. Patients in sepsis due to any other cause other than acute pancreatitis ruled out by detailed history and clinical examination.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
serum Calcium and Serum Lactate Ratio  At baseline (on admission) and on discharge 
 
Secondary Outcome  
Outcome  TimePoints 
ICU stay duration and complications  After admission and management during the course of hospitalisation 
 
Target Sample Size   Total Sample Size="49"
Sample Size from India="49" 
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)   30/09/2023 
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   Primary Purpose of Study
-Early detection of severity of acute pancreatitis with help of markers Serum Calcium and Serum Lactate, which can be readily available in laboratories, which is not time consuming and does not require experts to interpret the values/reports. 
- Categorizing acute pancreatitis into mild, moderate and severe using this ratio. Early detection of severe acute pancreatitis is important so as to deliver proper aggressive care to patient and to avoid its complications. 
-Early intervention. Better prognosis and reduced hospital stay duration when intervened early.

Study Hypothesis:
Hypocalcemia is consistent with severe acute pancreatitis and Lactate is a product of anaerobic metabolism of glucose and is generally considered to be a marker of tissue hypoxia. In addition, previous studies have also found that the presence of elevated arterial lactate levels reflects critical tissue hypoperfusion, which is strongly associated with increased morbidity and mortality in critically ill patients. A recent study has shown that elevated serum lactate is a new biomarker that could be an important tool in predicting poor outcomes of Acute Pancreatitis on admission, especially in predicting death. Thus, we assume that arterial lactate may be an important biomarker to stratify patients with Acute Pancreatitis. Hence, serum calcium and serum lactate (in mmol/L) can be useful to predict severity of cases early in disease onset as hypocalcaemia is found to be a poor prognostic marker and elevated lactate level is a marker of sepsis, tissue hypoxia and necrosis. Moreover much literature on serum calcium: serum lactate ratio levels have not been found.
 
Close