CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
IVTM™ System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141255
NCT03141255N/ACompleted
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Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)

University of Chicago·interventional·Posted May 5, 2017·Updated Apr 12, 2023

In Brief

A clinical study evaluating IVTM™ System and Quattro® Catheter for Cardiogenic Shock. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of the study is to compare patients with cardiogenic shock who receive standard therapy plus therapeutic hypothermia (TH) to patients with cardiogenic shock who receive standard medical therapy alone in order to assess the safety of TH in patients with cardiogenic shock. This study will also help understand the physiologic effects of TH in patients with cardiogenic shock. This will be a pilot study to establish the initial safety of TH and to assess tolerability of TH in this patient population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiogenic Shock
CountriesUnited States
CollaboratorsZOLL Circulation, Inc., USA

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2017
Enrollment StartNov 6, 2017
Primary CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.2 years ago

Interventions

IVTM™ Systemdevice

TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.

Quattro® Catheterdevice

TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.