Kidney FailureNCT01286506
Observational Study of Blood Pressure Measurements and Continuous Dialysis
An observational study of Kidney Failure and Respiratory Failure, run by University of Chicago at 1 site in United States.
Trial summary
Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Respiratory Failure, Critical Illness
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2015
- 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: Adult ICU patients requiring CVVHD who have an indwelling arterial line.
Who may be able to join
- age > 17 years old
- CVVHD renal replacement therapy
- indwelling arterial line
Who cannot join
- age < 18 years old
- pregnancy
- temperature < 34°C
- severe mechanical ventilator dyssynchrony
- cardiac arrhythmias precluding automated PPV measurement by ICU monitors
- non-pulsatile cardiac flow
- open thoracic cavity
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy
Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis.
We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.
- Conditions
- Kidney Failure, Respiratory Failure, Critical Illness, Shock
- Keywords
- Pulse pressure variation, Continuous venovenous hemodialysis, Volume status, Critical care
- Medical subject headings
- Renal Insufficiency, Respiratory Insufficiency, Critical Illness, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated patients | Not described | |
| Non-mechanically ventilated patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD
Measured: Iterative 24 hr periods for the duration of CRRT
Secondary outcomes (3)
Increased doses of vasoactive agents on CRRT
Measured: Iterative 24 hr periods for the duration of CRRT
Inability to meet goal ultrafiltration rate
Measured: Iterative 24 hr periods for the duration of CRRT
Hypotensive events on CRRT
Measured: Iterative 24 hr periods for the duration of CRRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael O'Connor, MD, Principal investigator, University of ChicagoJay L Koyner, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286506
- Sponsor's protocol ID
- 16710A
- Status last verified
- Aug 2016
- First submitted
- 27 Jan 2011
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01286506
- Acronym / sponsor ID
- 16710A
- Conditions
- Kidney Failure, Respiratory Failure, Critical Illness, Shock
- Keywords
- Pulse pressure variation, Continuous venovenous hemodialysis, Volume status, Critical care
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Jan 2011 (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.
Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis.
We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | – | – |
| Non-mechanically ventilated patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients requiring CVVHD who have an indwelling arterial line.
Key inclusion criteria (3 listed)
- age > 17 years old
- CVVHD renal replacement therapy
- indwelling arterial line
Key exclusion criteria (7 listed)
- age < 18 years old
- pregnancy
- temperature < 34°C
- severe mechanical ventilator dyssynchrony
- cardiac arrhythmias precluding automated PPV measurement by ICU monitors
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
Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD
Time frame: Iterative 24 hr periods for the duration of CRRT
3 secondary outcomes
Increased doses of vasoactive agents on CRRT
Time frame: Iterative 24 hr periods for the duration of CRRT
Inability to meet goal ultrafiltration rate
Time frame: Iterative 24 hr periods for the duration of CRRT
Hypotensive events on CRRT
Time frame: Iterative 24 hr periods for the duration of CRRT
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Michael O'Connor, MD principal investigator
University of Chicago
Jay L Koyner, MD principal investigator
University of Chicago
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 Kidney Failure and Respiratory Failure, run by University of Chicago 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Aug 2016. 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 stopped early. Results are not available in the source record.
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?
Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD (time frame: Iterative 24 hr periods for the duration of CRRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2016.