Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
This study has been completed.
Sponsor:
Haukeland University Hospital
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00468793
First received: May 2, 2007
Last updated: June 5, 2009
Last verified: May 2009
| Tracking Information | |||||
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| First Received Date ICMJE | May 2, 2007 | ||||
| Last Updated Date | June 5, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Postoperative morbidity [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Postoperative morbidity | ||||
| Change History | Complete list of historical versions of study NCT00468793 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
serum creatinine [ Time Frame: postoperative day 3 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Traditional Versus ScvO2 Guided Perioperative Fluid Therapy | ||||
| Official Title ICMJE | Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy | ||||
| Brief Summary | Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided by central venous oxygen saturation. The primary outcome will be complications after surgery. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Perioperative Care | ||||
| Intervention ICMJE | Procedure: Intravenous fluid
The same intravenous fluids will be used in both arms but the volume will be different |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Completion Date | May 2009 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00468793 | ||||
| Other Study ID Numbers ICMJE | 16312 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gro Østgaard, Haukeland University Hospital | ||||
| Study Sponsor ICMJE | Haukeland University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Haukeland University Hospital | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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