| CTRI Number |
CTRI/2024/08/072558 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Predictors of ICU outcome with Lactate Concentration, Base Excess and Alactic Base Excess (ABE) as in patients with sepsis and septic shock |
|
Scientific Title of Study
|
Lactate Concentration, Base Excess and Alactic Base Excess (ABE) as predictors of ICU outcome in patients with sepsis and septic shock :An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Afzal Azim |
| Designation |
Professor Critical Care Medicine |
| Affiliation |
Sanjay Gandhi Poatgraduate Institute of Medical Sciences, Raebareli Road, Lucknow |
| Address |
Department of Critical Care Medicine,Sanjay Gandhi Poatgraduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9984988393 |
| Fax |
|
| Email |
draazim2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish kumar sharma |
| Designation |
Senior resident |
| Affiliation |
DM senior resident |
| Address |
Department of Critical Care Medicine,Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8989843686 |
| Fax |
|
| Email |
dr.aaashishsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Afzal Azim |
| Designation |
Professor Critical Care Medicine |
| Affiliation |
Sanjay Gandhi Poatgraduate Institute of Medical Sciences, Raebareli Road, Lucknow |
| Address |
Department of Critical Care Medicine,Sanjay Gandhi Poatgraduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9984988393 |
| Fax |
|
| Email |
draazim2002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow |
| Address |
Department of critical Care Medicine Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow-226014 |
| 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 |
| DR Afzal Azim |
SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES LUCKNOW |
1st Floor, F block, DEPARTMENT OF CRITICAL CARE MEDICINE, SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES LUCKNOW, 226014
Lucknow
UTTAR PRADESH |
9984988393
draazim2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SGPGIMS, LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E874||Mixed disorder of acid-base balance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Patients with sepsis or septic shock
Acute kidney injury stage I and II
|
|
| ExclusionCriteria |
| Details |
AKI stage III
AKI on RRT
CKD patients eGFR less than 60
Patients on diuretic therapy at admission
Post renal transplant patients
Expected stay in ICU less than 72 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate BE, lactate, and ABE as a predictors of ICU outcome |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration and dose of vasopressors use in sepsis and septic shock patients
Days of vasopressor use
Stage and progression of AKI at admission and during ICU stay
Need of RRT during ICU stay
Total days of Mechanical ventilation
Total length of ICU stay / Total days of hospitalization.
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/08/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Project details- Shock is a life threatening hemodynamic emergency leading to hypo perfusion of tissue and cause severe metabolic changes at cellular level. Acid base imbalance in shock is due to low oxygen delivery to tissue, high oxygen consumption or inadequate utilization which leads to various metabolic derangements with or without hyperlactataemia. Hyperlactetemia may be accompanied by metabolic acidosis or as a separate entity not affecting the acid-base status. In 2019, Gattinoni et al introduced a new term alactic base excess (ABE) to differentiate between metabolic acidosis caused by lactate accumulation and non lactate fixed acids (unmeasured fixed ions) not eliminated by lungs, eg sulphates and phosphates. Conceptually ABE is the sum of negative values of base excess and lactate. The effect of ABE in septic patients was studied by Gattinoni at el and they concluded that it possibly reflects the impact of renal dysfunction on plasma lactate concentration and acid base balance. They also found that increased plasma lactate indicates sepsis severity and that ABE can be used to estimate renal capacity to handle acid base balance. “Alactic base excess†(ABE) recently introduced by Gattinoni et al is the sum of base excess and lactate (ABE= BE+L). ABE represents the number/concentration of abnormal strong acids other than lactate in plasma. Nevertheless, the predictive value of ABE has not yet been investigated in different septic shock patients and needs validation in ICU settings.so in this observational study we aim to investigate the further potential prognostic value of ABE and its contributors, i.e., lactate concentration and BE to predicting 28 days mortality in shock patients admitted in our ICU. Simultaneously we will examine duration and dose of vasopressors use in sepsis and septic shock patients,days of vasopressor use,stage and progression of AKI at admission and during ICU stay,need of RRT during ICU stay,total days of Mechanical ventilation,total length of ICU stay / total days of hospitalization as seconary objectives. |