| CTRI Number |
CTRI/2024/10/074767 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes Other (Specify) [pragmatic single centre parallel group, Accessor Blind investigator led randomized trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A single-center parallel-group randomized study to evaluate customized patient care with the standard of care as per the guidelines for the treatment of low blood pressure in seriously ill patients having shock, which means a sudden fall in blood pressure.
|
|
Scientific Title of Study
|
Individualized Resuscitation in Early Septic Shock( first 3 hours of Resuscitation) A single centre parallel group randomised controlled trial |
| Trial Acronym |
IRESS Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No 4236 Version 2.0 dated 15.12.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr.Earnest Borges Road, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr.Earnest Borges Road, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr.Earnest Borges Road, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road, Parel, Mumbai, Maharashtara India 400012 |
| 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 Sheila Myatra |
Tata Memorial Hospital, Mumbai |
Room No MB101 and MB201, Intensive Care Unit, First and Second floor, Main Building, Tata Memorial Hospital, Parel Mumbai MAHARASHTRA |
9820156070
sheila150@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, (2) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Management (IM) group |
In this group first of all fluid responsiveness is checked by dynamic measures. If patient is fluid responsive, 10 ml/kg (Ideal Body Weight) of IV crystalloids are given bolus and CRT & MAP are measured. If CRT is 3 sec or MAP 65 mmhg, another 10 ml/kg IV crystalloids are given. If the patient is mechanically ventilated, the variable used for reducing the rate of infusion will be increase in FiO2 requirement &/or PEEP to maintain target spo2 as decided by treating clinician. This fluid administration may be repeated if patient is fluid responsive and Fluid tolerant as discussed above until goals of resuscitation are met like MAP ≥ 65 mmhg & CRT ≤ 3 sec or Lactate 2 mmol/L |
| Comparator Agent |
Standard of Care management group |
In this group, patient will receive total of 30ml/kg of IBW Intravenous fluid boluses during the period of early sepsis i.e. 1st three hours. If the patient saturation falls &/or respiratory rate increased, the rate of administration and the total amount of fluid can be reduced as decided by the clinician. Here also the end target will be MAP 65 mmhg and CRT 3 sec. CRT will be measure after each 10ml/kg fluid bolus during our study period while lactate is measured at baseline and at 3 hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient (more than equal to 18 years) with sepsis induced hypotension or septic shock as per Sepsis 3 consensus conference |
|
| ExclusionCriteria |
| Details |
1. Received more than 10ml/kg of intravenous crystalloids before randomization in last 3 hours
2. Do not resuscitate status
3. Anticipated surgery or acute hemodialysis procedure to start during the first 3 hour period
4. Child B-C Cirrhosis
5. Pregnancy
6. Treating Physicians feel use of fluid bolus or vasopressor is strongly indicated or contraindicated
7. Age less than 18 years
8. Inability to take consent from surrogate
9.Vasopressors stopped less than 24 hours before
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All cause mortality within 28 days after randomization |
28 days after randomisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of ICU Stay. |
till discharge from Intensive care unit after enrollment |
| Number of days free from ventilator use (within 28 days after randomization). |
till day 28 or ICU discharge or Death, whichever come first |
| Days free from vasopressor use (within 28 days after randomization). |
till day 28 or ICU discharge or Death, whichever come first |
| Days free from Renal Replacement therapy (within 28 days after randomization) |
till day 28 or ICU discharge or Death, whichever come first |
| Death during period of early resuscitation (within 3 hours) |
upto 3 hrs post randomisation |
| Time to CRT normalization |
till day 28 or ICU discharge or Death, whichever come first |
| Lactate reduction by 3rd hour |
upto 3 hrs post randomisation |
|
|
Target Sample Size
|
Total Sample Size="350" Sample Size from India="350"
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)
|
28/10/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Fluid therapy is commonly necessary to treat
patients in the critical care unit who experience a fast drop in blood pressure
due to a bloodstream infection. IV fluids are quickly injected into the veins
of the patient as part of this fluid therapy. Only 50% of patients, meanwhile,
benefit from this fluid treatment and do not have organ failure. In the first
three hours of therapy, a patient in shock should receive at least 30
milliliters of intravenous fluid for every kilogram of body weight, according to
established standards. This lowers the risk of hypotension and septic shock,
although clinical research has not supported these recommendations.
However, not all low blood pressure patients
respond to fluid therapy in the same manner, which can have major adverse
effects like edema and excess fluid in the lungs that restrict oxygen flow. The
recommended standard volume of 30 ml/kg of body weight may not be enough for
certain persons, and it may induce an accumulation of extra water in blood
vessels for others. Therefore, it’s essential to utilize the right kind and
quantity of fluid while treating low blood pressure. Furthermore, it is
necessary to regularly assess the effects of fluid therapy because the 3-hour
treatment interval recommended by the conventional guidelines to do so is
unreliable.
Controlling the amount of fluid supplied requires a
thorough evaluation in order to avoid both excess- and less-treatment and the
associated complications. According to one study analysis, there is a
significant relationship between the decrease in number of deaths, a reduction
in ICU stay, and less time spent on breathing machines when fluid treatment is
given using the dynamic approach instead of the standard method. We want to conduct
this research to compare the benefits of customized management—using dynamic
assessments for evaluating the effect of fluid therapy and conventional
management using the standard amount of 30 ml/kg fluid volume for fluid
administration during the early stages of hypotension caused due to the severe
infections.
In this study, we are making the assumption that, using
a dynamic approach to fluid administration in the treatment of initial stages (i.e
first 3 hours of treatment) of hypotension resulting from a severe infection
will dramatically reduce the number of deaths as compare to the standard
method.
Benefits
The
patients enrolled in the trial may or may not be directly benefitted from participating
in the trial but the results obtained from the study may help the clinicians in
the treatment of future patient treatment.
Safety
Intervention
Any side
effects that occur during the treatment of early infection will be treated as
per the ICU doctor decision. Participants will receive all other medicines and
the standard of care treatment as per the ICU doctor’s decision during the
intervention period.
The
treating clinician and investigator may choose to reduce the fluid therapy and
rate of administration of fluids if necessary or even stop it if there is a
drop in oxygen level, an increase in respiratory rate, increase in an oxygen
demand, and/or pressure to provide oxygen. |