| CTRI Number |
CTRI/2012/08/002889 [Registered on: 14/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/07/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to see if there is a relationship of abnormal oxygen levels in the venous blood to the outcome of ICU care when admitted with serious infection and injury. |
|
Scientific Title of Study
|
A prospective observational trial to characterize the association of abnormal central venous saturation to the morbidity and mortality of patients admitted to the intensive care unit with a diagnosis of sepsis or trauma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Avula |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College Hospital |
| Address |
Department of Anaesthesia
Christian Medical college Hospital
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
09940784671 |
| Fax |
04162232305 |
| Email |
docjyothi99@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Subramani |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesia
Christian Medical College Hospital
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282693 |
| Fax |
04162232305 |
| Email |
ksubramani9@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Subramani |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesia
Christian Medical College Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282693 |
| Fax |
04162232305 |
| Email |
ksubramani9@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College Fluid Research Fund |
| Address |
c/o Vice Principal Research
Christian medical College Bagayam
Thorapadi (PO)
Vellore |
| 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 |
| Dr K Subramani |
Intensive care Unit |
Christian Medical College Hospital
Vellore
Vellore
TAMIL NADU |
04162282693
04162232305
ksubramani9@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Sepsis and Trauma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Admission to the ICU with diagnosis of sepsis and polytrauma. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years or above 80 years
2. Pregnant mothers
3. Known cases of chronic lung disease
4. Known cases of cardiac disease – moderate to severe left ventricular failure, Intra and extra cardiac shunts.
5. Liver failure – acute / chronic
6. Patients recruited in another trial
7.Patients with central venous catheter whose tip is not in the superior vena cava.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICU mortality |
ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of ICU stay
2. Duration of ventilation and ventilator free days
3. Necessity and duration of inotropic support
4. Need for dialysis
5. 28 days hospital mortality |
1. ICU stay
2. ICU stay
3. ICU stay
4. ICU and hospital stay
5. Hospital stay |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
02/05/2011 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Study is still ongoing |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Traditionally, low central venous haemoglobin saturation has been shown to be associated with poor outcome. Guidelines to normalise the central venous oxygen saturation have been published have been published. Some studies in post-operative cardiac surgical patients and patients with sepsis have shown that high central venous oxygen saturation has been associated with poor outcome. We wanted to see the effect of abnormal (both low and abnormally high values) on the morbidity and mortality of patients who are admitted to the Surgical Intensive Care unit with a diagnosis of sepsis and polytrauma. Patients received necessary resuscitation as deemed on admission to the ICU. Parameters were monitored at admission and 6 hours after admission, when the initial resuscitation would have concluded. |