PERSEUS-PS Randomized Controlled Trial

NCT04428060 | Terminated DMC

• 1 other identifier: UTHDA-AC02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The PERSEUS protocol is a new approach to the resuscitation of highly monitored patients with cardiac arrest. It aims at the optimization of all the available physiological parameters and the full exploitation of both the "cardiac pump" and "thoracic pump'. This protocol will help to titrate chest compressions, ventilation, and vasopressor dosing to physiological parameters, increasing survival after cardiac arrest with favorable neurological outcome

Conditions

Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation

Keywords

Resuscitation; Cardiac arrest; Physiology-guided treatment; Personalized treatment; Outcome; Physiology

Outcome Measures

Primary Outcomes (1)

• ROSC

  Return of spontaneous circulation

  From start of CPR until return of spontaneous circulation, assessed up to 60 minutes

Secondary Outcomes (5)

• ICU length of stay

  Up to 8 weeks

• Days on mechanical ventilation

  Up to 8 weeks

• Survival to hospital discharge

  Up to 8 weeks

• 1-month survival

  At 1 month after hopsital discharge

• 3-month survival

  At 3 months after hopsital discharge

Study Arms (2)

PERSEUS CPR

EXPERIMENTAL

Patients will be resuscitated according to the PERSEUS protocol

Other: PERSEUS CPR

CONTROL

ACTIVE COMPARATOR

Patients will be resuscitated according to current Advanced Life Support guidelines

Other: Standard CPR

Interventions

PERSEUS CPR OTHER

Resuscitation based on patient physiology

PERSEUS CPR

Standard CPR OTHER

Resuscitation based on current guidelines

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• invasive arterial blood pressure monitoring prior to and during CPR
• first compression of CPR captured on transmitted arterial blood pressure waveform data
• internal jugular or subclavian central venous catheter prior to and during CPR
• patients with measurement of systemic vascular resistance prior to and during CPR

You may not qualify if:

• unable to determine any of the aforementioned parameters during CPR
• unable to determine when CPR started and stopped

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, 41110, Greece

Location

Related Publications (7)

• Sutton RM, French B, Meaney PA, Topjian AA, Parshuram CS, Edelson DP, Schexnayder S, Abella BS, Merchant RM, Bembea M, Berg RA, Nadkarni VM; American Heart Association's Get With The Guidelines-Resuscitation Investigators. Physiologic monitoring of CPR quality during adult cardiac arrest: A propensity-matched cohort study. Resuscitation. 2016 Sep;106:76-82. doi: 10.1016/j.resuscitation.2016.06.018. Epub 2016 Jun 24.

  PMID: 27350369 BACKGROUND

• Jellinek H, Krenn H, Oczenski W, Veit F, Schwarz S, Fitzgerald RD. Influence of positive airway pressure on the pressure gradient for venous return in humans. J Appl Physiol (1985). 2000 Mar;88(3):926-32. doi: 10.1152/jappl.2000.88.3.926.

  PMID: 10710387 BACKGROUND

• Aya HD, Cecconi M. Can (and should) the venous tone be monitored at the bedside? Curr Opin Crit Care. 2015 Jun;21(3):240-4. doi: 10.1097/MCC.0000000000000199.

  PMID: 25887298 BACKGROUND

• Berg RA, Sutton RM, Reeder RW, Berger JT, Newth CJ, Carcillo JA, McQuillen PS, Meert KL, Yates AR, Harrison RE, Moler FW, Pollack MM, Carpenter TC, Wessel DL, Jenkins TL, Notterman DA, Holubkov R, Tamburro RF, Dean JM, Nadkarni VM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) PICqCPR (Pediatric Intensive Care Quality of Cardio-Pulmonary Resuscitation) Investigators. Association Between Diastolic Blood Pressure During Pediatric In-Hospital Cardiopulmonary Resuscitation and Survival. Circulation. 2018 Apr 24;137(17):1784-1795. doi: 10.1161/CIRCULATIONAHA.117.032270. Epub 2017 Dec 26.

  PMID: 29279413 BACKGROUND

• Chalkias A, Xanthos T. Timing positive-pressure ventilation during chest compression: the key to improving the thoracic pump? Eur Heart J Acute Cardiovasc Care. 2015 Feb;4(1):24-7. doi: 10.1177/2048872613516923. Epub 2013 Dec 12.

  PMID: 24381094 BACKGROUND

• Chalkias A, Pavlopoulos F, Koutsovasilis A, d'Aloja E, Xanthos T. Airway pressure and outcome of out-of-hospital cardiac arrest: A prospective observational study. Resuscitation. 2017 Jan;110:101-106. doi: 10.1016/j.resuscitation.2016.10.023. Epub 2016 Nov 10.

  PMID: 27840003 BACKGROUND

• Chalkias A, Arnaoutoglou E, Xanthos T. Personalized physiology-guided resuscitation in highly monitored patients with cardiac arrest-the PERSEUS resuscitation protocol. Heart Fail Rev. 2019 Jul;24(4):473-480. doi: 10.1007/s10741-019-09772-7.

  PMID: 30741366 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Athanasios Chalkias, MD, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: June 12, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)