| 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
|
|
|
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
|
|
|
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. |