Septic Shock Management Guided by Ultrasound: SEPTICUS Trial

NCT04728529 | Unknown

• 1 other identifier: University of Brawijaya
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

septic shock; Doppler ultrasonography; Fluid resuscitation; Vasoactive therapy; Mortality rate; Fluid overload

Outcome Measures

Primary Outcomes (2)

• Mortality rate

  Time of mortality occurrence since randomization, comparing intervention and control group.

  72 hours of the initial fluid resuscitation

• Number of mortality

  Amount of non-survivor subject, comparing intervention and control group.

  72 hours of the initial fluid resuscitation

Secondary Outcomes (13)

• Heart rate

  1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated

• Capillary refill time

  1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated

• Peripheral pulse strength

  1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated

• Systolic blood pressure

  1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated

• Mean arterial pressure

  1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated

Study Arms (2)

USSM protocol

EXPERIMENTAL

patient in the intervention group receive fluid resuscitation and inotropic-vasoactive agent, if needed, in accordance to USSM protocol of fluid resuscitation.

Procedure: USSM protocol

ACCM protocol

EXPERIMENTAL

patient in the control group receive fluid resuscitation and inotropic-vasoactive agent, if needed, in accordance to ACCM protocol of fluid resuscitation.

Procedure: ACCM protocol

Interventions

USSM protocol PROCEDURE

In the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical and USCOM examination. If any improvement of clinical sign and normal SVI, CI, SVR, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by USCOM. The therapeutic goal of USCOM: SVI 30-60 mL/m2, CI 3.3-6.0 L/minute/m2, and SVRI 800-1600 d.s/cm5/m2

USSM protocol

ACCM protocol PROCEDURE

In the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical. If any improvement of clinical sign, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by clinical parameter.

ACCM protocol

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saptadi Yuliarto: lead

Study Sites (1)

RSUD dr. Saiful Anwar

Malang, East Java, 65145, Indonesia

RECRUITING

Related Publications (8)

• Davis 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.

  PMID: 28509730 BACKGROUND

• Weiss 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. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.

  PMID: 32032273 BACKGROUND

• Weiss 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.

  PMID: 32030529 BACKGROUND

• Santhanam I, Sangareddi S, Venkataraman S, Kissoon N, Thiruvengadamudayan V, Kasthuri RK. A prospective randomized controlled study of two fluid regimens in the initial management of septic shock in the emergency department. Pediatr Emerg Care. 2008 Oct;24(10):647-55. doi: 10.1097/PEC.0b013e31818844cf.

  PMID: 19242131 BACKGROUND

• Ranjit S, Aram G, Kissoon N, Ali MK, Natraj R, Shresti S, Jayakumar I, Gandhi D. Multimodal monitoring for hemodynamic categorization and management of pediatric septic shock: a pilot observational study*. Pediatr Crit Care Med. 2014 Jan;15(1):e17-26. doi: 10.1097/PCC.0b013e3182a5589c.

  PMID: 24196006 BACKGROUND

• Ceneviva G, Paschall JA, Maffei F, Carcillo JA. Hemodynamic support in fluid-refractory pediatric septic shock. Pediatrics. 1998 Aug;102(2):e19. doi: 10.1542/peds.102.2.e19.

  PMID: 9685464 BACKGROUND

• Horster S, Stemmler HJ, Strecker N, Brettner F, Hausmann A, Cnossen J, Parhofer KG, Nickel T, Geiger S. Cardiac Output Measurements in Septic Patients: Comparing the Accuracy of USCOM to PiCCO. Crit Care Res Pract. 2012;2012:270631. doi: 10.1155/2012/270631. Epub 2011 Nov 29.

  PMID: 22191019 BACKGROUND

• Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.

  PMID: 15636651 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Edema

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms

Study Officials

• Saptadi Yuliarto, MD

  University of Brawijaya

  STUDY DIRECTOR

Central Study Contacts

Saptadi Yuliarto, MD

CONTACT

+6281233053652; saptadiy@ub.ac.id

Nur Hidayati Azhar, MD

CONTACT

+62 822-4509-9109; nur.hidayati.azhar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome of mortality rate, macrocirculation hemodynamic parameter, and microcirculation laboratory parameter are objective measurement (does not influenced by assessors's subjectiveness). However, the assessor of liver enlargement and lung US score will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Pediatric Emergency and Intensive Care Department

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 28, 2021
• Study Start: September 2, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

ID (1)