SepsisPhase 2ANDES-CHILDNCT06478797
Early Resuscitation in Paediatric Sepsis Using Inotropes
A Phase 2 study testing Fluid and Adrenalin in people with Sepsis, run by NATALIA LOPERA MUNERA at 4 sites in 3 countries.
Trial summary
Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Fluid and Adrenalin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 28 days and <18 years
- Treated for sepsis
- Received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock
- Parental/caregiver consent prior to or after enrolment
Who cannot join
- Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- Received ≥ 40 mL/kg of fluid boluses during the 4 h pre-enrolment
- Inotrope infusion commenced pre-enrolment
- Lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment
- Cardiomyopathy or chronic cardiac failure
- Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment
Show all 13Show fewer
- Known chronic renal failure (defined as requiring renal replacement therapy)
- Known chronic hepatic failure
- Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)
- Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of >2min duration, or death is deemed to be imminent or inevitable during this admission.
- Major bleeding with haemorrhagic shock
- Sepsis is not likely to be the cause of shock
- Previous enrollment in ANDES-CHILD
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Paraguay2 sites
Hospital De Clínicas
Asunción
Ricardo Iramain, MD, +595 981300491, iramainricardo@gmail.com
Ricardo Iramain, MD
Hospital Niños de Acosta Ñu
San Lorenzo
Viviana Pavlicich, MD, +595 971206043, p_viviana@hotmail.com
Viviana Pavlicich, MD
Argentina1 site
Hospital de Niños "Dr. Orlando Alassia"
Santa Fe
Rodolfo Pacce, MD, +54 9 3424350350, rodolfopacce2000@yahoo.com.ar
Rodolfo Pacce, MD
Bolivia1 site
Hospital Regional San Juan De Dios Tarija
Tarija
Nils Casson, MD, +591 7 6187393, nilsjefe1@hotmail.com
Nils Casson, MD
About this study
Official title: Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)
Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)
- Conditions
- Sepsis
- Being tested
- Fluid, Adrenalin
- Keywords
- pediatric sepsis, septic shock, inotropes, adrenaline, emergency department, fluid, child
- Medical subject headings
- Sepsis, Shock, Septic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluidOther
Sepsis will be treated with standardized therapy protocol, where participants receive fluids (balanced or non-balanced crystalloids, or colloids) to be resuscitated. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes.
AdrenalinDrug
Sepsis will be treated with early inotropes, where participants will receive adrenaline at a dose of 0.05 - 0.1 mcg/kg/min via peripheral intravenous, intraosseous, or central venous routes after the first fluid bolus of 20 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Sepsis will be treated with a standardized therapy protocol, where participants will receive fluids for resuscitation. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes Receives: Other: Fluid |
| Intervention group | Experimental | Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg Receives: Drug: Adrenalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival free of organ support at 28 days
Organ support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy
Measured: From time of randomization until 28 days, if death occurs, time is set to 0 days
Secondary outcomes (18)
Recuitment rates
Secondary feasibility outcome 1
Measured: 12 months
Proportion of eligible randomised
Other feasibility 2
Measured: 12 months
Proportion of eligible consented using perspective consent and consent to continue
Other feasibility 3
Measured: 12 months
Time to initiation of inotropes between the control and the early inotrope arm
Other feasibility 4
Measured: 24 hours
Amount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm
Other feasibility 5
Measured: 24 hours
Protocol violations
Other feasibility 6. Percentage of patients not treated according to the assigned group.
Measured: 12 months
Survival free of inotrope support at 7 days
Secondary exploratory clinical outcome 1
Measured: 7 days
Survival free of invasive ventilation support at 7 days
Secondary exploratory clinical outcome 2
Measured: 7 days
28-day mortality
Secondary exploratory clinical outcome 3
Measured: From time of randomization until 28 days
Survival free of PICU censored at 28 days
Secondary exploratory clinical outcome 4
Measured: 28 days
PICU length of stay
Secondary exploratory clinical outcome 5
Measured: 28 days
Hospital length of stay
Secondary exploratory clinical outcome 6
Measured: 28 days
Functional Status Score at 28 days
Secondary exploratory clinical outcome 7
Measured: 28 days
Modified Pediatric Overall Performance Category at 28 days
Secondary exploratory clinical outcome 7
Measured: 28 days
Amount of fluid (mLs per kg) received during the first hour, and by 4, 12, and 24 hour post enrolment
Secondary exploratory clinical outcome 8
Measured: 24 hours
Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment
Secondary exploratory clinical outcome 9
Measured: 24 hours
Time to reversal of tachycardia during the first 24 h
Secondary exploratory clinical outcome 10
Measured: 24 hours
Time to shock reversal, defined as cessation of inotropes for at least 4 h censored at 28 days
Secondary exploratory clinical outcome 11
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a two-armed control study. One of the arms is the control group, so a group of participants, that is being treated with the standard therapy. The other arm is the intervention group, a group of participants that is being treated with adrenaline. It will be random which child is assigned to which group, this insures that the study is not biased.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NATALIA LOPERA MUNERA
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital, Zurich, Universidad Nacional del Nordeste, Argentina, Instituto Latino Americano de Sepse, Hospital Pablo Tobón Uribe
- Responsible party
- Sponsor-investigator, NATALIA LOPERA MUNERA, Hospital General Pediátrico Niños de Acosta Ñu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478797
- Sponsor's protocol ID
- IRB: 00006311
- Acronym
- ANDES-CHILD
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Schlapbach LJ, Kissoon N. Defining Pediatric Sepsis. JAMA Pediatr. 2018 Apr 1;172(4):312-314. doi: 10.1001/jamapediatrics.2017.5208. No abstract available.
PubMed 29459982Scott HF, Brou L, Deakyne SJ, Kempe A, Fairclough DL, Bajaj L. Association Between Early Lactate Levels and 30-Day Mortality in Clinically Suspected Sepsis in Children. JAMA Pediatr. 2017 Mar 1;171(3):249-255. doi: 10.1001/jamapediatrics.2016.3681.
PubMed 28068437Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
PubMed 31954465Schlapbach LJ, Straney L, Alexander J, MacLaren G, Festa M, Schibler A, Slater A; ANZICS Paediatric Study Group. Mortality related to invasive infections, sepsis, and septic shock in critically ill children in Australia and New Zealand, 2002-13: a multicentre retrospective cohort study. Lancet Infect Dis. 2015 Jan;15(1):46-54. doi: 10.1016/S1473-3099(14)71003-5. Epub 2014 Dec 1.
PubMed 25471555Schlapbach LJ, Aebischer M, Adams M, Natalucci G, Bonhoeffer J, Latzin P, Nelle M, Bucher HU, Latal B; Swiss Neonatal Network and Follow-Up Group. Impact of sepsis on neurodevelopmental outcome in a Swiss National Cohort of extremely premature infants. Pediatrics. 2011 Aug;128(2):e348-57. doi: 10.1542/peds.2010-3338. Epub 2011 Jul 18.
PubMed 21768312Kirsten R, Heintz B, Nelson K, Oremek G, Speck U. Influence of two guar preparations on glycosylated hemoglobin, total cholesterol and triglycerides in patients with diabetes mellitus. Int J Clin Pharmacol Ther Toxicol. 1992 Dec;30(12):582-6.
PubMed 1335441Reinhart K, Daniels R, Kissoon N, Machado FR, Schachter RD, Finfer S. Recognizing Sepsis as a Global Health Priority - A WHO Resolution. N Engl J Med. 2017 Aug 3;377(5):414-417. doi: 10.1056/NEJMp1707170. Epub 2017 Jun 28. No abstract available.
PubMed 28658587Schlapbach LJ, Kissoon N, Alhawsawi A, Aljuaid MH, Daniels R, Gorordo-Delsol LA, Machado F, Malik I, Nsutebu EF, Finfer S, Reinhart K. World Sepsis Day: a global agenda to target a leading cause of morbidity and mortality. Am J Physiol Lung Cell Mol Physiol. 2020 Sep 1;319(3):L518-L522. doi: 10.1152/ajplung.00369.2020. Epub 2020 Aug 19. No abstract available.
PubMed 32812788Schlapbach LJ, Thompson K, Finfer SR. The WHO resolution on sepsis: what action is needed in Australia? Med J Aust. 2019 Nov;211(9):395-397.e1. doi: 10.5694/mja2.50279. Epub 2019 Jul 22. No abstract available.
PubMed 31329300Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med. 2020 Feb;46(Suppl 1):10-67. doi: 10.1007/s00134-019-05878-6.
PubMed 32030529Evans IVR, Phillips GS, Alpern ER, Angus DC, Friedrich ME, Kissoon N, Lemeshow S, Levy MM, Parker MM, Terry KM, Watson RS, Weiss SL, Zimmerman J, Seymour CW. Association Between the New York Sepsis Care Mandate and In-Hospital Mortality for Pediatric Sepsis. JAMA. 2018 Jul 24;320(4):358-367. doi: 10.1001/jama.2018.9071.
PubMed 30043064Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, Okhuysen-Cawley RS, Relvas MS, Rozenfeld RA, Skippen PW, Stojadinovic BJ, Williams EA, Yeh TS, Balamuth F, Brierley J, de Caen AR, Cheifetz IM, Choong K, Conway E Jr, Cornell T, Doctor A, Dugas MA, Feldman JD, Fitzgerald JC, Flori HR, Fortenberry JD, Graciano AL, Greenwald BM, Hall MW, Han YY, Hernan LJ, Irazuzta JE, Iselin E, van der Jagt EW, Jeffries HE, Kache S, Katyal C, Kissoon N, Kon AA, Kutko MC, MacLaren G, Maul T, Mehta R, Odetola F, Parbuoni K, Paul R, Peters MJ, Ranjit S, Reuter-Rice KE, Schnitzler EJ, Scott HF, Torres A Jr, Weingarten-Arams J, Weiss SL, Zimmerman JJ, Zuckerberg AL. American College of Critical Care Medicine Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock. Crit Care Med. 2017 Jun;45(6):1061-1093. doi: 10.1097/CCM.0000000000002425.
PubMed 28509730Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26.
PubMed 21615299Sinitsky L, Walls D, Nadel S, Inwald DP. Fluid overload at 48 hours is associated with respiratory morbidity but not mortality in a general PICU: retrospective cohort study. Pediatr Crit Care Med. 2015 Mar;16(3):205-9. doi: 10.1097/PCC.0000000000000318.
PubMed 25581632
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)
- ClinicalTrials.gov ID
- NCT06478797
- Acronym / sponsor ID
- ANDES-CHILD / IRB: 00006311
- Conditions
- Sepsis
- Keywords
- pediatric sepsis, septic shock, inotropes, adrenaline, emergency department, fluid, child
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NATALIA LOPERA MUNERAUniversity, hospital or other
- Collaborators
- University Children's Hospital, Zurich, Universidad Nacional del Nordeste, Argentina, Instituto Latino Americano de Sepse, Hospital Pablo Tobón Uribe
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a two-armed control study. One of the arms is the control group, so a group of participants, that is being treated with the standard therapy. The other arm is the intervention group, a group of participants that is being treated with adrenaline. It will be random which child is assigned to which group, this insures that the study is not biased.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: FluidSepsis will be treated with a standardized therapy protocol, where participants will receive fluids for resuscitation. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes |
| Intervention group | Experimental | Drug: AdrenalinSepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 28 days and <18 years
- Treated for sepsis
- Received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock
- Parental/caregiver consent prior to or after enrolment
Key exclusion criteria (13 listed)
- Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- Received ≥ 40 mL/kg of fluid boluses during the 4 h pre-enrolment
- Inotrope infusion commenced pre-enrolment
- Lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment
- Cardiomyopathy or chronic cardiac failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluidSepsis will be treated with standardized therapy protocol, where participants receive fluids (balanced or non-balanced crystalloids, or colloids) to be resuscitated. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes. | Other | Control group |
| AdrenalinSepsis will be treated with early inotropes, where participants will receive adrenaline at a dose of 0.05 - 0.1 mcg/kg/min via peripheral intravenous, intraosseous, or central venous routes after the first fluid bolus of 20 ml/kg | Drug | Intervention group |
Primary outcome
Survival free of organ support at 28 days
Time frame: From time of randomization until 28 days, if death occurs, time is set to 0 days
Organ support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy
18 secondary outcomes
Recuitment rates
Time frame: 12 months
Proportion of eligible randomised
Time frame: 12 months
Proportion of eligible consented using perspective consent and consent to continue
Time frame: 12 months
Time to initiation of inotropes between the control and the early inotrope arm
Time frame: 24 hours
Amount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm
Time frame: 24 hours
Protocol violations
Time frame: 12 months
Survival free of inotrope support at 7 days
Time frame: 7 days
Survival free of invasive ventilation support at 7 days
Time frame: 7 days
28-day mortality
Time frame: From time of randomization until 28 days
Survival free of PICU censored at 28 days
Time frame: 28 days
PICU length of stay
Time frame: 28 days
Hospital length of stay
Time frame: 28 days
Functional Status Score at 28 days
Time frame: 28 days
Modified Pediatric Overall Performance Category at 28 days
Time frame: 28 days
Amount of fluid (mLs per kg) received during the first hour, and by 4, 12, and 24 hour post enrolment
Time frame: 24 hours
Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment
Time frame: 24 hours
Time to reversal of tachycardia during the first 24 h
Time frame: 24 hours
Time to shock reversal, defined as cessation of inotropes for at least 4 h censored at 28 days
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 29459982Schlapbach LJ, Kissoon N. Defining Pediatric Sepsis. JAMA Pediatr. 2018 Apr 1;172(4):312-314. doi: 10.1001/jamapediatrics.2017.5208. No abstract available.
- Background: PubMed 28068437Scott HF, Brou L, Deakyne SJ, Kempe A, Fairclough DL, Bajaj L. Association Between Early Lactate Levels and 30-Day Mortality in Clinically Suspected Sepsis in Children. JAMA Pediatr. 2017 Mar 1;171(3):249-255. doi: 10.1001/jamapediatrics.2016.3681.
- Background: PubMed 31954465Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
- Background: PubMed 25471555Schlapbach LJ, Straney L, Alexander J, MacLaren G, Festa M, Schibler A, Slater A; ANZICS Paediatric Study Group. Mortality related to invasive infections, sepsis, and septic shock in critically ill children in Australia and New Zealand, 2002-13: a multicentre retrospective cohort study. Lancet Infect Dis. 2015 Jan;15(1):46-54. doi: 10.1016/S1473-3099(14)71003-5. Epub 2014 Dec 1.
- Background: PubMed 21768312Schlapbach LJ, Aebischer M, Adams M, Natalucci G, Bonhoeffer J, Latzin P, Nelle M, Bucher HU, Latal B; Swiss Neonatal Network and Follow-Up Group. Impact of sepsis on neurodevelopmental outcome in a Swiss National Cohort of extremely premature infants. Pediatrics. 2011 Aug;128(2):e348-57. doi: 10.1542/peds.2010-3338. Epub 2011 Jul 18.
- Background: PubMed 1335441Kirsten R, Heintz B, Nelson K, Oremek G, Speck U. Influence of two guar preparations on glycosylated hemoglobin, total cholesterol and triglycerides in patients with diabetes mellitus. Int J Clin Pharmacol Ther Toxicol. 1992 Dec;30(12):582-6.
- Background: PubMed 28658587Reinhart K, Daniels R, Kissoon N, Machado FR, Schachter RD, Finfer S. Recognizing Sepsis as a Global Health Priority - A WHO Resolution. N Engl J Med. 2017 Aug 3;377(5):414-417. doi: 10.1056/NEJMp1707170. Epub 2017 Jun 28. No abstract available.
- Background: PubMed 32812788Schlapbach LJ, Kissoon N, Alhawsawi A, Aljuaid MH, Daniels R, Gorordo-Delsol LA, Machado F, Malik I, Nsutebu EF, Finfer S, Reinhart K. World Sepsis Day: a global agenda to target a leading cause of morbidity and mortality. Am J Physiol Lung Cell Mol Physiol. 2020 Sep 1;319(3):L518-L522. doi: 10.1152/ajplung.00369.2020. Epub 2020 Aug 19. No abstract available.
- Background: PubMed 31329300Schlapbach LJ, Thompson K, Finfer SR. The WHO resolution on sepsis: what action is needed in Australia? Med J Aust. 2019 Nov;211(9):395-397.e1. doi: 10.5694/mja2.50279. Epub 2019 Jul 22. No abstract available.
- Background: PubMed 32030529Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med. 2020 Feb;46(Suppl 1):10-67. doi: 10.1007/s00134-019-05878-6.
- Background: PubMed 30043064Evans IVR, Phillips GS, Alpern ER, Angus DC, Friedrich ME, Kissoon N, Lemeshow S, Levy MM, Parker MM, Terry KM, Watson RS, Weiss SL, Zimmerman J, Seymour CW. Association Between the New York Sepsis Care Mandate and In-Hospital Mortality for Pediatric Sepsis. JAMA. 2018 Jul 24;320(4):358-367. doi: 10.1001/jama.2018.9071.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluid and Adrenalin in people with Sepsis, run by NATALIA LOPERA MUNERA at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Paraguay, Argentina, Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia Lopera, MD (+57 3122978381, natalialoperam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival free of organ support at 28 days (time frame: From time of randomization until 28 days, if death occurs, time is set to 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06478797, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.