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NCT00848393 · ClinicalTrials.gov registry record · Phase 2

Measures to Lower the Stress Response in Pediatric Cardiac Surgery

A Phase 2 study of Tetralogy of Fallot (TOF) and Ventricular Septal Defects (VSD), sponsored by Nationwide Children's Hospital.

Completed
Registry status
Phase 2
Development phase
52
Enrollment target
1
Study location

NCT00848393 is a Phase 2 study of Tetralogy of Fallot (TOF) and Ventricular Septal Defects (VSD) that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 52 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT00848393, a Phase 2 study of Tetralogy of Fallot (TOF) and Ventricular Septal Defects (VSD), has completed, sponsored by Nationwide Children's Hospital.

COMPLETED
Registry status
Phase 2
Development phase
52 participants
Enrollment target
1
Study location

Study Summary

Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively. Through clinical observation, anesthesiologists have determined that varying the combinations of anesthesia drugs used during surgery and just after reduces the stress response, and by extension, morbidity and mortality. However, only a few studies have explored this phenomenon scientifically.

Interventions

  • DRUG Fentanyl (High Dose)
  • DRUG Fentanyl (Low Dose)
  • DRUG Fentanyl (Low Dose) + Dexmedetomidine

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2008-11
Est. Completion 2013-12
Phase Phase 2

Sponsor

Nationwide Children's Hospital

188 total trials

What the Registry Record Tells You About NCT00848393

The ClinicalTrials.gov registry entry for NCT00848393 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Tetralogy of Fallot (TOF) appearing as the primary indexed condition, and to 3 interventions - of which Fentanyl (High Dose) is the first listed.

NCT00848393 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT00848393 about?

NCT00848393 is a clinical study titled "Measures to Lower the Stress Response in Pediatric Cardiac Surgery". Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively. Through clinical observation, anesthesiologists have determined that varying the combinations of anesthesia drugs used during surgery and just after reduces the stress ...

What is the current status of trial NCT00848393?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2008-11. Estimated completion is 2013-12.

What conditions does trial NCT00848393 study?

This clinical trial studies the following conditions: Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD), Atrioventricular Septal Defects (AVSD).

What interventions are being tested in trial NCT00848393?

The interventions under investigation include: Fentanyl (High Dose) (DRUG), Fentanyl (Low Dose) (DRUG), Fentanyl (Low Dose) + Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT00848393?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00848393 being conducted?

This trial has 1 study location across Ohio. 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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