| CTRI Number |
CTRI/2023/10/058869 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Understand the relationship between PCO2 gap, calculated respiratory quotient and serum lactate in patients with septic shock. |
|
Scientific Title of Study
|
To study correlation between venous to arterial carbon dioxide difference
(Pv-aCO2), PcvCO2-PaCO2/ CaO2-CcvO2
ratio and serum lactate during resuscitation in patients with septic shock. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DANISH AHMAD |
| Designation |
DrNB RESIDENT |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL VAISHALI |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, MAX SUPER SPECIALITY HOSPITAL, SECTOR 1, VAISHALI, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
7887077978 |
| Fax |
|
| Email |
DANISHHORIZON@ROCKETMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANISH GUPTA |
| Designation |
DIRECTOR |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL VAISHALI |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, MAX SUPER SPECIALITY HOSPITAL, SECTOR 1, VAISHALI, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9868081770 |
| Fax |
|
| Email |
MANISH.GUPTA@MAXHEALTHCARE.COM |
|
Details of Contact Person
Public Query
|
| Name |
DANISH AHMAD |
| Designation |
DrNB RESIDENT |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL VAISHALI |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, MAX SUPER SPECIALITY HOSPITAL, SECTOR 1, VAISHALI, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
7887077978 |
| Fax |
|
| Email |
DANISHHORIZON@ROCKETMAIL.COM |
|
|
Source of Monetary or Material Support
|
| MAX SUPERSPECIALITY HOSPITAL, VAISHALI GHAZIABAD |
|
|
Primary Sponsor
|
| Name |
DANISH AHMAD |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, MAX SUPER SPECIALITY HOSPITAL, SECTOR 1, VAISHALI, GHAZIABAD |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DANISH AHMAD |
MAX SUPER SPECIALITY HOSPITAL |
MICU 7 , 7 th floor tower 1/
MICU 6 , 6th floor tower 1
DEPARTMENT OF CRITICAL CARE MEDICINE,
Ghaziabad
UTTAR PRADESH |
7887077978
DANISHHORIZON@ROCKETMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAX SUPER SPECIALITY HOSPITAL, VAISHALI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS ADMITTED WITH SEPTIC SHOCK |
|
| ExclusionCriteria |
| Details |
-Patients with all types of Shock other than Septic Shock.
- Trauma Patients.
- Pregnant Patients.
- ARDS, COPD Patients.
- Seizure Disorder patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate correlation between Pv-aCO2, PcvCO2– PaCO2/CaO2–CcvO2 ratio and the arterial lactate at various time points till 24 hours, in management of patients with septic shock.
|
To evaluate correlation between Pv-aCO2, PcvCO2– PaCO2/CaO2–CcvO2 ratio and the arterial lactate at various time points 0,6 ,12, 24 hours, in management of patients with septic shock.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To ascertain whether the Pv-aCO2, PcvCO2–PaCO2/CaO2–CcvO2 ratio and the arterial lactate levels in the first 24 hours are able to predict outcome of the patient in terms of: -
a. Organ dysfunction at 48 hours, as assessed by (SOFA) score
b. Vasopressor free days.
c. Length of stay in ICU.
d. Mortality within 28 days.
|
28 days. |
| To determine whether the Pv-aCO2, PcvCO2–PaCO2/ CaO2–CcvO2 ratio and arterial lactate are useful in discriminating survivors from non-survivors. |
Survivor from non survivor |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
01/11/2023 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To study the correlation between venous to arterial carbon dioxide difference (Pv-aCO2), PcvCO2-PaCO2/CaO2-CcvO2 ratio and serum lactate during resuscitation in patients with septic shock. Objectives: Primary Objective- To evaluate correlation between Pv-aCO2, PcvCO2–PaCO2/CaO2–CcvO2 ratio and the arterial lactate at various time points till 24 hours, in management of patients with septic shock. Secondary Objectives- To ascertain whether the Pv-aCO2, PcvCO2–PaCO2/CaO2–CcvO2 ratio and the arterial lactate levels in the first 24 hours are able to predict outcome of the patient in terms of: -a.Organ dysfunction at 48 hours, as assessed by Sequential Organ Failure Assessment (SOFA) score (range, 0 [best] to 24 [worst]). b. Vasopressor free days. c. Length of stay in ICU. d. Mortality within 28 days. To determine whether the Pv-aCO2, PcvCO2–PaCO2/ CaO2–CcvO2 ratio and arterial lactate are useful in discriminating survivors from non-survivors.
|