The benefits of early inotropic administration compared to refractory phase inotropic administration in pediatric patients with septic shock
| ISRCTN | ISRCTN40192699 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40192699 |
| Secondary identifying numbers | C4 277 |
- Submission date
- 12/01/2023
- Registration date
- 26/01/2023
- Last edited
- 25/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Septic shock, particularly protracted or refractory shock episodes, is a significant cause of morbidity and mortality in the pediatric critical care unit. According to current guidelines, only stubborn cases have received inotrope administration in the therapy of septic shock; however, there have not been many investigations to determine whether earlier administration could improve outcomes.
Inotropic medications are drugs that affect the contractility of the heart muscle. They can be used to increase or decrease the strength of the heart's contractions.
This study compares the effects of giving epinephrine immediately after resuscitation or giving it an hour later.
Who can participate?
Pediatric patients with septic shock
What does the study involve?
The effects on septic shock will be measured by several laboratory parameters, including peripheral oxygen saturation, leukocyte count, c-reactive protein (CRP), ferritin, troponin I, and serum lactate levels.
What are the possible benefits and risks of participating?
Benefits: There is a .possible benefit of early inotrope administration
Risks: Minimal risk due to early epinephrine infusion, as the authors and attending paediatricians monitored patients strictly. Early epinephrine infusion has also been regarded as safe according to sepsis guidelines in our centre.
Where is the study run from?
Udayana University (Indonesia)
When is the study starting and how long is it expected to run for?
April 2019 to April 2021
Who is funding the study?
Udayana University (Indonesia)
Who is the main contact?
Dr Dyah Kanyawati, dyahkanyawati@unud.ac.id
Contact information
Principal Investigator
Jalan Jayagiri XIII no.2A
Denpasar
80234
Indonesia
 ORCID ID |
0000-0002-6633-7445 |
|---|---|
| Phone | +62 1285705152 |
| dyahkanyawati@unud.ac.id |
Scientific
Jalan Jayagiri XIII no.2A
Denpasar
80234
Indonesia
| tjoksenapathi@unud.ac.id |
Public
Jalan Jayagiri XIII no.2A
Denpasar
80234
Indonesia
| wiradewi@unud.ac.id |
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43036 PIS.pdf |
| Scientific title | Improvement of serum ferritin levels with inotropic administration in early phase compared to refractory phase in pediatric patients with septic shock: a preliminary randomized controlled trial study |
| Study acronym | Early Phase Inotropic Administration in Pediatric Septic Shock (EPIASS study) |
| Study objectives | Early use of inotropes agent in refractory septic shock cases result in lower ferritin level especially in the first hour after administration. |
| Ethics approval(s) | Approved 18/05/2020, Komisi Etik Penelitan (Jalan P. Serangan Denpasar, Bali, Indonesia; +62 361244534; infofk@unud.ac.id), ref: 1034/UN14.2.2.VII.14/LT/2020 |
| Health condition(s) or problem(s) studied | Improvement in the outcome of pediatric patients with septic shock by early administration of inotropic |
| Intervention | Pediatric patients who first came to the paediatric ED in Prof. dr. IGNG Ngoerah Hospital in the study period of December 2019 until December 2020 with a diagnosis of septic shock according to the history, physical examination, as well as a scoring system based on the diagnostic criteria for septic shock were included in the study. Data collection proceeded only after consent was initially taken from parents. Patient’s blood samples were collected (CRP levels, leukocytes, troponins, serum ferritin, lactate levels and oxygen saturation) as initial markers. Study participants were randomly allocated into two groups: an early group who received immediate epinephrine infusion (0.05–0.3 μg/kg/min via infusion pumps through peripheral catheters and were shifted to a central line as soon as the line was established) and participants who received epinephrine infusion 1 hour after fluid resuscitation. Patients’ allocations were randomly determined to classify the study groups, the random sequence was computer generated using www.sealedenvelope.com. After a patient enrolled, the paediatric resident on duty supervision of the paediatrician on duty opened the sealed envelope and initiated the study drug according to allocations. Blood samples (CRP levels, leukocytes, troponins, serum ferritin, lactate levels and oxygen saturation) were collected again after the patient is given epinephrine infusion either in the early phase or after the refractory phase at the first, 6 and 24 hours. The paediatrician on duty made the decision to taper or increase the inotropes agent according to the patient’s clinical condition. Participants were not followed after initial management and care in the ER, data were only taken according to participants’ conditions in the paediatric ER. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Epinephrine |
| Primary outcome measure | Ferritin levels in blood samples measured using a ferritin test at 1, 6, and 24 hours following the administration of epinephrine |
| Secondary outcome measures | Levels in blood samples at 1, 6, and 24 hours following administration of epinephrine: 1. Leukocytes measured using a white blood cell count 2. C-Reactive Protein (CRP) measured using a CRP test 3. Troponin-I measured using a troponin test 4. Lactate measured using a lactic acid test 5. Oxygen saturation measured using a pulse oximeter |
| Overall study start date | 01/04/2019 |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 13 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Pediatric patients diagnosed with septic shock and presenting to the pediatric emergency department of RS Prof Ngoerah between December 2019 and December 2020 2. Pediatric patients whose parents agree to sign the informed consent |
| Key exclusion criteria | 1. Pediatric patients with congenital diseases, such as congenital heart disease 2. Undergoing therapy for renal diseases 3. History of prematurity 4. Fluid resuscitation has been done in other healthcare facilities |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Denpasar
80361
Indonesia
Sponsor information
University/education
Kampus Bukit
Jl. Raya Kampus Unud Jimbaran
Badung
80361
Indonesia
| Phone | +62 361701954 |
|---|---|
| info@unud.ac.id | |
| Website | https://www.unud.ac.id |
"ROR" |
https://ror.org/035qsg823 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Udayana University, University of Udayana, Udayana University Rectorate, UNUD
- Location
- Indonesia
Results and Publications
| Intention to publish date | 01/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current studi aare/will be available upon request from Dyah Kanyawati (email: dyahkanyawati@unud.ac.id) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/01/2023 | No | Yes | ||
| Protocol file | 25/01/2023 | No | No |
Additional files
Editorial Notes
25/01/2023: Trial's existence confirmed by Komisi Etik Penelitan.
