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NCT04366310 · ClinicalTrials.gov registry record

Capillary Refill Index with Rewarming

A clinical trial, sponsored by Nihon Kohden.

Terminated
Registry status
65
Enrollment target

NCT04366310: Clinical Trial study, sponsored by Nihon Kohden.

NCT04366310 is a clinical trial that was terminated before completion, run by Nihon Kohden. The registered enrollment target is 65 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04366310 was terminated before completion, sponsored by Nihon Kohden.

TERMINATED
Registry status
65 participants
Enrollment target

Study Summary

A new technology, capillary refill index (CRI) can be useful for assessing peripheral perfusion status quantitatively, but this value can be influenced by fingertip temperature. The aim of this study is to evaluate the predictive accuracy of CRI after a temperature control (warming) procedure in predicting 30-day mortality among ICU/CCU patients. The investigators hypothesized that lowered fingertip temperature can lead prolonged CRI values which are considered as false positives in detection of high-risk patients for mortality, because it causes poor peripheral perfusion which does not reflect hemodynamic instability. The investigators will use the warming procedure to remove or reduce the effect of the fingertip temperature on the CRI measurement and will analyze whether it contributes to reduction of false positives in detection of high-risk patients for mortality.

Primary Outcome

Receiver operator characteristic (ROC) curve analysis of CRI after the temperature control procedure for 30 days mortality of ICU patients will be performed and area under the curve (AUC) will be calculated.

Interventions

  • DEVICE capillary refill index
  • PROCEDURE rewarming

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2020-11-16
Est. Completion 2023-03-01
Nihon Kohden

14 total trials

Why NCT04366310 stopped before completion

NCT04366310 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 65 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which capillary refill index is the first listed.

NCT04366310 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04366310 about?

NCT04366310 is a clinical study titled "Capillary Refill Index with Rewarming". A new technology, capillary refill index (CRI) can be useful for assessing peripheral perfusion status quantitatively, but this value can be influenced by fingertip temperature. The aim of this study is to evaluate the predictive accuracy of CRI after a temperature control (warming) procedure in pre...

What is the current status of trial NCT04366310?

This trial is currently terminated. The enrollment target is 65 participants. The study started on 2020-11-16. Estimated completion is 2023-03-01.

What interventions are being tested in trial NCT04366310?

The interventions under investigation include: capillary refill index (DEVICE), rewarming (PROCEDURE).

Who is sponsoring clinical trial NCT04366310?

This trial is sponsored by Nihon Kohden, which has 14 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04366310, the US trial registry maintained by the National Library of Medicine. NCT04366310 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.