Clinical trial NCT04728529: Septic Shock Management Guided by Ultrasound: SEPTICUS Trial
Official title: Septic Shock Management Guided by Ultrasound: A Randomized Control Trial (SEPTICUS Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
Doppler ultrasonography
Fluid resuscitation
Vasoactive therapy
Mortality rate
Fluid overload
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 340
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each eligible patient will be randomized into 2 groups of treatment, the USSM protocol or the ACCM protocol. All of subjects in each group will receive emergency management: oxygen support, vascular access, and fluid resuscitation. In intervention group, each step of fluid and vasoactive management will be guided by clinical sign and Doppler ultrasonography, whereas in control group only guided by the clinical sign.
Primary purpose: TREATMENT

Brief summary: This clinical study aims to compare the recent septic shock management protocol from American College of Critical Care Medicine (ACCM) to Ultrasound-guided Septic Shock Management (USSM) protocol. USSM protocol laid on Doppler ultrasonography to evaluate stroke volume, cardiac index, and systemic vascular resistance in each step of management to decide the proper fluid resuscitation and vasoactive therapy; differs from ACCM protocol which use clinical finding in its early step. ACCM protocol application elicits risk of improper therapy since clinical sign per se often could not describe the certain cardiac output. This can be prevented earlier by USSM protocol. The outcome compared of the two protocols is: mortality rate, clinical parameter, macrocirculation hemodynamic parameter, laboratory microcirculation parameter, and signs of fluid overload. The investigators hypothesized if the USSM protocol had a better outcome and less fluid overload complication.

Detailed description: This study is a randomized controlled trial to compare the usage of ACCM protocol and USSM protocol in fluid resuscitation for septic shock pediatric patients. The USSM protocol is the intervention, and the ACCM protocol is the control. This study implemented in septic shock pediatric patients treated in the intensive care unit. Each patient will be randomized into 2 groups, the USSM group or the ACCM group. In the initial step, all patient in each group will receive early acute/emergency therapy: oxygen support, vascular access, and fluid resuscitation. The monitoring of the patient including clinical parameters and laboratory examination for both groups, except Doppler ultrasonography that performed in each step of management of the intervention group. The monitoring is performed every 15 minutes in the first hour of resuscitation. If the patient show good response (fluid responsive shock), the monitoring stops in 1 hour. In contrast, if the patient reveal fluid refractory shock, the vasoactive agent will be administered and monitoring continues until 6 hours. All outcome parameters, except mortality rate, will be recorded at 6 hours. The mortality rates will be recorded at 72 hours and time of intensive care discharge.

Sample size in this study was calculated by clinical trial formula for mortality rate with a significance level of 0.05 and study power of 0.2. From the calculation, the subject needed is 170 patients for each group (total 340 subjects). The basic characteristics of the patient will be analyzed descriptively. All parameter data will be analyzed statistically by Statistical Product and Service Solution (SPSS) 20, preceded by normality test and homogeneity test. The study analysis will be intention-to-treat. The mortality rate was analyzed by Kaplan-Meier survival analysis. Data transformation will be performed if needed in case of outlier data or out-of-range results.

Eligibility criteria: Inclusion Criteria:

* diagnosed as septic shock according to Pediatric Surviving Campaign (2005)

Exclusion Criteria:

* patient with uncorrected congenital heart disease with shunting
* obtain fluid resuscitation before recruitment process
* obtain inotropic-vasoactive agent before recruitment process
* after undergo any heart surgery

Primary outcomes:
measure: Mortality rate
timeFrame: 72 hours of the initial fluid resuscitation
measure: Number of mortality
timeFrame: 72 hours of the initial fluid resuscitation
Secondary outcomes:
measure: Heart rate
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Capillary refill time
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Peripheral pulse strength
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Systolic blood pressure
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Mean arterial pressure
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Systemic vascular resistance index
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Stroke volume index
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Cardiac index
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Base deficit
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Blood lactate level
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Liver span increase
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Lung ultrasound score
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
measure: Vasoactive-inotropic score (VIS)
timeFrame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Other outcomes:
Locations:
city: Malang
country: Indonesia
facility: RSUD dr. Saiful Anwar
state: Jawa Timur
Study officials:
affiliation: University of Brawijaya
name: Saptadi Yuliarto, MD
role: STUDY_DIRECTOR
References:
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