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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: Completed Phase 2 study of Tetralogy of Fallot (TOF) and Ventricular Septal Defects (VSD), sponsored by Nationwide Children's Hospital.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
N = 48 n = 16 (LDF); n = 17 (HDF); n = 15 (LDF + Dex) ACTH assayed by enzyme-linked immunosorbent assay (ELISA); Cytokine levels in plasma were measured using the Immulite automated chemiluminometer. Measured cytokines include interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-α.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2008-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00848393 record still lists
NCT00848393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00848393's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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