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NCT03915587 · ClinicalTrials.gov registry record · NA

Bedside Resources to Gauge Intravascular Volume Status

A NA study of Hypovolemia and Craniosynostoses, sponsored by University of Colorado, Denver.

Completed
Registry status
NA
Development phase
23
Enrollment target
1
Study location

NCT03915587 is a NA study of Hypovolemia and Craniosynostoses that has completed, run by University of Colorado, Denver. The registered enrollment target is 23 participants, below the 59-participant average among 5 other Hypovolemia trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03915587, a NA study of Hypovolemia and Craniosynostoses, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
NA
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

The goal if this study is to employ the CardioQ-Esophageal Aortic Doppler probe to define fluid responders from non-responders among infants undergoing cranial vault reconstruction for craniosynostosis. After defining these two groups in this single arm prospective trial, the investigators will compare the predictive utility of non-invasive devices such as the CipherOx-Compensatory Reserve Index (CipherOx-CRI) and Inferior Vena Cava Collapsibility Index (IVC CI) to currently employed indices (heart rate, systolic blood pressure, urine output and pulse pressure variability) to gauge the need for additional fluid and ongoing resuscitation. If the CipherOx-CRI or IVC CI proved to be as predictive or better at predicting fluid responders, the investigators hope to replace invasive arterial lines with non-invasive tools to guide resuscitation.

Interventions

  • DEVICE CardioQ-EDM and CipherOx-CRI

Study Locations (1)

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2019-04-08
Est. Completion 2020-03-12
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT03915587

The ClinicalTrials.gov registry entry for NCT03915587 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 59-participant average among 5 other Hypovolemia trials with a reported enrollment target (61% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hypovolemia appearing as the primary indexed condition, and to 1 intervention - of which CardioQ-EDM and CipherOx-CRI is the first listed.

NCT03915587 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT03915587 about?

NCT03915587 is a clinical study titled "Bedside Resources to Gauge Intravascular Volume Status". The goal if this study is to employ the CardioQ-Esophageal Aortic Doppler probe to define fluid responders from non-responders among infants undergoing cranial vault reconstruction for craniosynostosis. After defining these two groups in this single arm prospective trial, the investigators will comp...

What is the current status of trial NCT03915587?

This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2019-04-08. Estimated completion is 2020-03-12.

What conditions does trial NCT03915587 study?

This clinical trial studies the following conditions: Hypovolemia, Craniosynostoses.

What interventions are being tested in trial NCT03915587?

The interventions under investigation include: CardioQ-EDM and CipherOx-CRI (DEVICE).

Who is sponsoring clinical trial NCT03915587?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03915587 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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