| CTRI Number |
CTRI/2019/07/020080 [Registered on: 08/07/2019] Trial Registered Prospectively |
| Last Modified On: |
05/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes
Other (Specify) [Use of a monitoring modality ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial of non-invasive (applied to body externally) continuous circulation monitoring for the management of severe infection and shock (impaired circulation and fall in blood pressure) in children. |
|
Scientific Title of Study
|
Non-invasive continuous hemodynamic monitoring (Electrocardiometry) for the management of paediatric septic shock - A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mounika Reddy Vadhi |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Pediatrics
St. Johns Medical College Hospital, St Johns National Academy of Medical Sciences, Sarjapur Main Rd, Johnnagara, Koramangala, Bangalore
Sarjapur Main Rd, Johnnagara, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065000 |
| Fax |
|
| Email |
doc.mounikareddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mounika Reddy Vadhi |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Pediatrics
St. Johns Medical College Hospital, St Johns National Academy of Medical Sciences, Sarjapur Main Rd, Johnnagara, Koramangala, Bangalore
Sarjapur Main Rd, Johnnagara, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065000 |
| Fax |
|
| Email |
doc.mounikareddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mounika Reddy Vadhi |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of Pediatrics
St. Johns Medical College Hospital, St Johns National Academy of Medical Sciences, Sarjapur Main Rd, Johnnagara, Koramangala, Bangalore
Sarjapur Main Rd, Johnnagara, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065000 |
| Fax |
|
| Email |
doc.mounikareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Johns Medical College Hospital, Sarjapura Road, Koramangala, Bangalore - 560034 |
|
|
Primary Sponsor
|
| Name |
Dr Mounika Reddy |
| Address |
Dept of Pediatrics, St Johns Medical College Hospital, Sarjapura road, Koramangala, Bangalore, 560034 |
| 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 |
| Dr Mounika Reddy |
St. Johns Medical College Hospital |
Pediatric Intensive Care Unit, 3rd Floor, Dept. of Pediatrics, St. Johns Medical College and Hospital, Sarjapur Main Rd, Johnnagara, Koramangala, Bangalore 560034
Bangalore
KARNATAKA |
08022065000
doc.mounikareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SJMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-invasive continuous hemodynamic monitoring (electrocardiometry) |
Use of Non-invasive continuous hemodynamic monitoring (electrocardiometry) to guide management of septic shock in children |
| Comparator Agent |
Standard care clinical monitoring |
Standard care clinical monitoring for the study purpose is defined as - clinical assessment, continuous invasive arterial blood pressure monitoring and bedside focussed echocardiography to assess volume status and cardiac contractility |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2 months to 18 years with early septic shock, defined as children with suspect or confirmed sepsis and unresolved shock/hypoperfusion after the initial 20ml/kg fluid bolus. |
|
| ExclusionCriteria |
| Details |
1. Children with fulminant myocarditis
2. Children with unrepaired congenital heart disease
3. Post-arrest cardiac dysfunction and shock
4. Children with severe acute malnutrition
5. Children with chronic kidney disease
6. Moribund patients with anticipated survival < 24 hrs
7. Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the fluid volume requirement in the first 6 hours (0-6 hours) between the two groups |
Difference in the fluid volume requirement in the first 6 hours (0-6 hours) between the two groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| o Proportion of children achieving shock resolution at 6, 12, 24, 48 and 72 hours of resuscitation. |
6, 12, 24, 48 and 72 hours |
| o Organ dysfunction scores (pSOFA and PELOD-2) at 24, 48 and 72 hours |
24, 48 and 72 hours |
| o Length of PICU stay and hospital stay |
length of stay |
| Mortality |
28 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/07/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Accurate
hemodynamic assessments are necessary to guide therapy (including fluids,
vasoactives, inotropes) in pediatric septic shock. Traditional clinical monitoring
is not accurate enough for hemodynamic categorization to guide management.
Invasive cardiac output monitoring with pulmonary artery catheter (PAC) is the
gold standard, however it is associated with risks. Continuous monitoring
allowing for real-time therapy guidance helps in optimizing fluid
administration and/or drug titrations for time-sensitive, goal directed
resuscitation which improves outcomes in pediatric septic shock.
Electrocardiometry has been validated for non-invasive continuous hemodynamic
monitoring in children and adults. However, whether it will provide better
guidance regarding management of pediatric septic shock compared to standard
care clinical monitoring alone is not known, and whether this translates into
better important patient centred outcomes like reduced mortality and morbidity
is not known, hence the need for this study. |