Resuscitation in Paediatric Sepsis Using Early Inotropes (RESPOND-ED)

Phase 2

Recruiting

• Conditions: Sepsis; Septic Shock; Infection - Studies of infection and infectious agents; Emergency medicine - Resuscitation

• Registration Number: ACTRN12619000828123
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Reword to:
Children age =>28days and <18 years where the decision is made by the treating physician to launch the institutional paediatric sepsis bundle treating for sepsis or septic shock. To be eligible, the child must have received at least 20ml/kg of intravenous fluid bolus(es) in the past four hours with the clinician deciding to continue treating for signs of shock.

Exclusion Criteria

- Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- Children who received =>40ml/kg of fluid during the 4 hours pre enrolment
- Children on Inotrope infusion
- Lack of access (intraosseus, central venous, peripheral) to administer fluids and/or inotropes after 60minutes of enrolment.
- Known cardiomyopathy or chronic cardiac failure
- Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment.
- Known chronic renal failure
- Known chronic hepatic failure
- Palliative care patient/patient with limitation of treatment (not for inotropes, CPR, ECLS, intubation and ventilation)
- Cardiopulmonary arrest in the past two hours requiring CPR >2 min, 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
- Enrolment in RESPOND study <6 months ago (except for RESPOND ED randomization prior to RESPOND PICU within the same sepsis episode)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main feasibility outcome is compliance with study protocol during the pilot. <br><br>We will assess the prospective hospital charts (including electronic health records and paper-based charts) and the study case report form to assess compliance with the study protocol.[28 days after randomisation];The primary outcome is defined as survival free of organ dysfunction, censored at 28 days.<br><br>We will access the prospective hospital charts (including electronic health records and paper-based charts) and the study case report form to assess organ dysfunction as defined by established organ dysfunction scoring using laboratory and clinical variables. Organ dysfunction will be defined as per the 2005 International Pediatric Sepsis Consensus Definition Conference criteria.[28 days after randomisation]