HemodynamicsNCT00739089
Presep and Vascath Interaction Study
An observational study of Hemodynamics and Renal Dialysis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamics, Renal Dialysis, Sepsis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: medical intensive care unit (MICU) patients in an academic tertiary care referral medical center.
Who may be able to join
- Admitted to the MICU
- PreSep venous oxygen saturation central venous catheter already in place
- VasCath central venous dialysis catheter already in place
- Planned hemodialysis
Who cannot join
- Patient unable to undergo hemodialysis
- Contraindication for PreSep or VasCath catheters
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study to Compare the Interaction Between Central Venous Mixed Venous Oxygen Saturation Catheters and Central Venous Hemodialysis Catheters
This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.
Read the detailed description
The central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.
- Conditions
- Hemodynamics, Renal Dialysis, Sepsis, Shock
- Keywords
- hemodynamics, oxygen, renal dialysis, shock, sepsis, hypotension, lactic acidosis
- Medical subject headings
- Sepsis, Shock, Hypotension, Acidosis, Lactic
What is being measured
The primary outcome is the main question the study is designed to answer.
change in SvO2
Measured: before and afer initiation of dialysis via a vascath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Study stopped due to a lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjun B Chatterjee, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739089
- Sponsor's protocol ID
- IRB00004073
- Status last verified
- Jan 2017
- First submitted
- 20 Aug 2008
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: de-identified data would have been shared with any other investigator with a local IRB approved protocol to evaluate de-identified patient data
Publications
Vaziri ND, Wilson A, Mukai D, Darwish R, Rutz A, Hyatt J, Moreno C. Dialysis hypoxemia. Role of dialyzer membrane and dialysate delivery system. Am J Med. 1984 Nov;77(5):828-33. doi: 10.1016/0002-9343(84)90519-9.
PubMed 6496536Jakob SM, Ruokonen E, Vuolteenaho O, Lampainen E, Takala J. Splanchnic perfusion during hemodialysis: evidence for marginal tissue perfusion. Crit Care Med. 2001 Jul;29(7):1393-8. doi: 10.1097/00003246-200107000-00015.
PubMed 11445693Krafft P, Steltzer H, Hiesmayr M, Klimscha W, Hammerle AF. Mixed venous oxygen saturation in critically ill septic shock patients. The role of defined events. Chest. 1993 Mar;103(3):900-6. doi: 10.1378/chest.103.3.900.
PubMed 8449089De Backer WA, Verpooten GA, Borgonjon DJ, Vermeire PA, Lins RR, De Broe ME. Hypoxemia during hemodialysis: effects of different membranes and dialysate compositions. Kidney Int. 1983 May;23(5):738-43. doi: 10.1038/ki.1983.87. No abstract available.
PubMed 6876569Quebbeman EJ, Maierhofer WJ, Piering WF. Mechanisms producing hypoxemia during hemodialysis. Crit Care Med. 1984 Apr;12(4):359-63. doi: 10.1097/00003246-198404000-00004.
PubMed 6705543Murray P, Hall J. Renal replacement therapy for acute renal failure. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):777-81. doi: 10.1164/ajrccm.162.3.ncc400. No abstract available.
PubMed 10988080
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare the Interaction Between Central Venous Mixed Venous Oxygen Saturation Catheters and Central Venous Hemodialysis Catheters
- ClinicalTrials.gov ID
- NCT00739089
- Acronym / sponsor ID
- IRB00004073
- Conditions
- Hemodynamics, Renal Dialysis, Sepsis, Shock
- Keywords
- hemodynamics, oxygen, renal dialysis, shock, sepsis, hypotension, lactic acidosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study stopped due to a lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.
Detailed description
The central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- medical intensive care unit (MICU) patients in an academic tertiary care referral medical center.
Key inclusion criteria (4 listed)
- Admitted to the MICU
- PreSep venous oxygen saturation central venous catheter already in place
- VasCath central venous dialysis catheter already in place
- Planned hemodialysis
Key exclusion criteria (2 listed)
- Patient unable to undergo hemodialysis
- Contraindication for PreSep or VasCath catheters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in SvO2
Time frame: before and afer initiation of dialysis via a vascath
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 6496536Vaziri ND, Wilson A, Mukai D, Darwish R, Rutz A, Hyatt J, Moreno C. Dialysis hypoxemia. Role of dialyzer membrane and dialysate delivery system. Am J Med. 1984 Nov;77(5):828-33. doi: 10.1016/0002-9343(84)90519-9.
- Background: PubMed 11445693Jakob SM, Ruokonen E, Vuolteenaho O, Lampainen E, Takala J. Splanchnic perfusion during hemodialysis: evidence for marginal tissue perfusion. Crit Care Med. 2001 Jul;29(7):1393-8. doi: 10.1097/00003246-200107000-00015.
- Background: PubMed 8449089Krafft P, Steltzer H, Hiesmayr M, Klimscha W, Hammerle AF. Mixed venous oxygen saturation in critically ill septic shock patients. The role of defined events. Chest. 1993 Mar;103(3):900-6. doi: 10.1378/chest.103.3.900.
- Background: PubMed 6876569De Backer WA, Verpooten GA, Borgonjon DJ, Vermeire PA, Lins RR, De Broe ME. Hypoxemia during hemodialysis: effects of different membranes and dialysate compositions. Kidney Int. 1983 May;23(5):738-43. doi: 10.1038/ki.1983.87. No abstract available.
- Background: PubMed 6705543Quebbeman EJ, Maierhofer WJ, Piering WF. Mechanisms producing hypoxemia during hemodialysis. Crit Care Med. 1984 Apr;12(4):359-63. doi: 10.1097/00003246-198404000-00004.
- Background: PubMed 10988080Murray P, Hall J. Renal replacement therapy for acute renal failure. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):777-81. doi: 10.1164/ajrccm.162.3.ncc400. No abstract available.
- Individual participant dataSharing planned: Yes. de-identified data would have been shared with any other investigator with a local IRB approved protocol to evaluate de-identified patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arjun B Chatterjee, MD, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamics and Renal Dialysis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in SvO2 (time frame: before and afer initiation of dialysis via a vascath). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739089, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.