| CTRI Number |
CTRI/2018/04/013294 [Registered on: 16/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patients admitted in higher facility hospitals and in sepsis are evaluated. Comparison of mortality predictors like lactate/albumin ratio with apache 2 score to know the outcome |
|
Scientific Title of Study
|
"Evaluation and comparison of lactate/albumin ratio with apache 2 assessment score for prognosis of sepsis in a tertiary care ICU" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi krishna kanth |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Room no: 18
2nd floor, Sharada Madhav Pai OPD building.
Department of General medicine.
KMC Manipal
Kasturba hospital
Madhavanagar
Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9491755868 |
| Fax |
|
| Email |
ravikrishnakanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Raghavendra rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college |
| Address |
Room no: 15
2nd floor, Sharada Madhav Pai OPD building.
Department of General medicine.
KMC Manipal
Kasturba hospital
Madhavanagar
Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9901731924 |
| Fax |
|
| Email |
ragsmanipal1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Raghavendra rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college |
| Address |
Room no: 15
2nd floor, Sharada Madhav Pai OPD building.
Department of General medicine.
KMC Manipal
Kasturba hospital
Madhavanagar
Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9901731924 |
| Fax |
|
| Email |
ragsmanipal1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba hospital
kasturba medical college
madhavnagar
manipal-
karnataka
576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba hospital |
| Address |
Madhavanagar
Manipal - 576104
Madhavanagar
Manipal - 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ravi krishnakanth |
Kasturba hospital |
Department of General Medicine
kasturba medical college
Udupi
KARNATAKA |
9491755868
ravikrishnakanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KASTURBA HOSPITAL, MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients admitted with sepsis into a tertiary care hospital., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-80 years of either sex with a definite diagnosis meeting sepsis criteria |
|
| ExclusionCriteria |
| Details |
Myocardial infarction
Hemorrhagic shock
Trauma
Seizure
Pregnancy
Chronic kidney disease
Chronic liver disease
Discharged against medical advice
Unconfirmed diagnosis
Not giving informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients survived and number of patients expired at end of ICU stay and comparison of their Lactate-albumin ratio at admission. |
Number of patients survived and number of patients expired at end of ICU stay and comparison of their Lactate-albumin ratio at admission. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify prognosis of sepsis |
To identify prognosis of sepsis |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/01/2018 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
New patients with confirmed sepsis seen in the department will be recruited during the period of the study. All clinical and lab details including previous history of disease status will be taken after the patients meeting exclusion and inclusion criteria. Patients with sepsis as per ACCP guidelines will be analyzed, their clinical and microbiological profile will be studied. APACHE II score will be calculated on day 1 and Lactate/albumin ratio is assessed on day 1.The scores will be used for predicting the outcome .The utility of these scores in predicting the mortality rate will be studied. |