Correspondence of ScO2 and Cardiac Output in Hemodialysis
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 2, 2010 | ||||
| Last Updated Date | December 2, 2010 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| 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 | Correspondence of ScO2 and Cardiac Output in Hemodialysis | ||||
| Official Title ICMJE | ScO2 and Cardiac Output - Correspondence Study in Hemodialysis Patients | ||||
| Brief Summary | The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Hemodialysis patients |
||||
| Condition ICMJE | Hemodialysis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Hemodialysis patients | ||||
| Publications * | Cordtz J, Olde B, Solem K, Ladefoged SD. Central venous oxygen saturation and thoracic admittance during dialysis: new approaches to hemodynamic monitoring. Hemodial Int. 2008 Jul;12(3):369-77. | ||||
|
* 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 37 | ||||
| Estimated Completion Date | November 2011 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Ambulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology. Exclusion Criteria: Age below 18 years. Failure to give informed consent. |
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01252394 | ||||
| Other Study ID Numbers ICMJE | ScO2 cardiac output | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joakim Cordtz/MD, Department of Nephrology, Copenhagen University Hospital | ||||
| Study Sponsor ICMJE | Danish State Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Danish State Hospital | ||||
| Verification Date | October 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||