| CTRI Number |
CTRI/2019/05/018882 [Registered on: 01/05/2019] Trial Registered Prospectively |
| Last Modified On: |
30/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
To know the role of carbondioxide partial pressure difference in central venous and arterial blood in the outcome of patients diagnosed with sepsis. |
|
Scientific Title of Study
|
Role Of Central Venous-Arterial Carbondioxide Partial Pressure Difference As A Prognostic Marker For The Outcome Of Septic Patients In ICU |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Gupta |
| Designation |
Consultant and professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9818623450 |
| Fax |
|
| Email |
p.gupta182@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Gupta |
| Designation |
Consultant and professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9818623450 |
| Fax |
|
| Email |
p.gupta182@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Gupta |
| Designation |
Consultant and professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9818623450 |
| Fax |
|
| Email |
p.gupta182@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care,Ground floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital |
|
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Primary Sponsor
|
| Name |
Department of Anesthesiology Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology, Ground floor,Main OT building,Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi -110029
New Delhi
DELHI |
9789007283
vaishalissri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, V.M.M.C and Safdarjung Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in presence of suspected infection
2.Patients who fulfill SOFA scores ≥ 2
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Terminally ill patients |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the role of pCO2 gap ( central Venous-Arterial carbon dioxide partial pressure difference )in sepsis and septic shock patients in relation to mortality and length of ICU stay
|
pCO2( partial pressure of carbon dioxide) , blood lactate levels, Scvo2(central venous oxygen saturation),hemodynamic parameters, MAP(mean arterial pressure), CVP (central venous pressure) will recorded at T0 , T6 and T24 and every day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the role played by pCO2 gap to guide in resuscitation of septic shock patients to stabilize the hemodynamic parameters and blood lactate concentrations.
2. To find the correlation between central venous-arterial pCO2 difference and ScvO2
|
pCO2(partial pressure of carbon dioxide) , blood lactate levels, Scvo2(central venous oxygen saturation),hemodynamic parameters, MAP(mean arterial pressure), CVP (central venous pressure) will recorded at T0 , T6 and T24 and every day |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/05/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
1.To assess the role of central Venous-Arterial carbon dioxide partial pressure difference in sepsis and septic shock patients in relation to mortality and the length of ICU stay 2.To guide in resuscitation of septic shock patients to stabilize hemodynamic parameters and blood lactate concentration 3.To find the correlation between central Venous-Arterial carbon dioxide partial pressure difference and central venous oxygen saturation.
|