IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction
This study has been completed.
Sponsor:
Erasmus Medical Center
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00335010
First received: June 7, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
| Tracking Information | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 7, 2006 | |||||||||||||||
| Last Updated Date | June 7, 2006 | |||||||||||||||
| Start Date ICMJE | May 2005 | |||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||
| Current Primary Outcome Measures ICMJE |
|
|||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
| Change History | No Changes Posted | |||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
|||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||||||||
| Descriptive Information | ||||||||||||||||
| Brief Title ICMJE | Intravenous NTG to Preserve Gastric Microcirculation During Gastric Tube Reconstruction | |||||||||||||||
| Official Title ICMJE | A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction | |||||||||||||||
| Brief Summary | The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage. | |||||||||||||||
| Detailed Description | Complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis, which may be due to compromised microvascular blood flow (MBF) in the gastric tissue. We recently demonstrated that peri-operatively decreased MBF could be improved by topical administration of nitro-glycerine NTG). In this present study we investigate the effect of intravenous NTG on gastric microcirculation. This single centre, prospective, double blinded study randomized thirty-two patients scheduled for esophagectomy into two groups. The intervention group received intravenous NTG during gastric tube reconstruction, as the control group received normal saline. Baseline values of MBF, microvascular haemoglobin O2 saturation (μHbSO2), and microvascular haemoglobin concentration (μHbcon) were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck. |
|||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||
| Study Phase | Not Provided | |||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
|||||||||||||||
| Condition ICMJE |
|
|||||||||||||||
| Intervention ICMJE | Drug: Nitroglycerin | |||||||||||||||
| Study Arms | Not Provided | |||||||||||||||
| Publications * |
|
|||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||||||||
| Recruitment Information | ||||||||||||||||
| Recruitment Status ICMJE | Completed | |||||||||||||||
| Enrollment ICMJE | 32 | |||||||||||||||
| Estimated Completion Date | December 2005 | |||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||||||||
| Sex/Gender |
|
|||||||||||||||
| Ages | 18 Years and older (Adult, Senior) | |||||||||||||||
| Accepts Healthy Volunteers | No | |||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
| Listed Location Countries ICMJE | Netherlands | |||||||||||||||
| Removed Location Countries | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number ICMJE | NCT00335010 | |||||||||||||||
| Other Study ID Numbers ICMJE | MEC-2004-160 | |||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||
| IPD Sharing Statement | Not Provided | |||||||||||||||
| Responsible Party | Not Provided | |||||||||||||||
| Study Sponsor ICMJE | Erasmus Medical Center | |||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||
| Investigators ICMJE |
|
|||||||||||||||
| PRS Account | Erasmus Medical Center | |||||||||||||||
| Verification Date | June 2006 | |||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||||||||