Peridialytic HypotensionNCT01171352
Predicting Hypotension During Dialysis in the ICU
An observational study of Peridialytic Hypotension, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Currently, decisions regarding volume management for dialysis sessions in the ICU are made in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peridialytic Hypotension
- What is being tested?
- Transpulmonary Thermodilution
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2010to 11 Mar 2013
- 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: Any patient 18 years and older who is admitted to the OHSU Hospitals ICUs with ARF, or End Stage Renal Disease (ESRD) for a diagnosis other than hyperkalemia, as the sole determinant for that level of care, will be invited to participate. The patient must have acute or chronic needs for dialytic support during their ICU stay in order to qualify for the study. Dialysis support may be provided by intermittent HD sessions, or continuous venovenous hemodiafiltration (CVVHDF) depending on the underlying hemodynamic stability of the patient.
Who may be able to join
- Admitted to OHSU Hospitals ICUs
- Patient has acute or chronic needs for intermittent hemodialysis support during their ICU stay for any reason other than isolated hyperkalemia
- Central venous access in place separate from the dialysis catheter, or arteriovenous fistula or graft
- Two or more organ systems affected by critical illness requiring supportive care as documented in the medical chart.
Who cannot join
- age younger than 18 years old
- Weight > 160 kg
- burns greater than 40% total body surface area
- known cardiac or vascular aneurysm
- contraindications to femoral arterial puncture
- diagnosis of peripheral vascular disease
Show all 13Show fewer
- not committed to full support
- participation in other experimental medication trial within 30 days
- current atrial or ventricular arrhythmias
- history of sever CHF- NYHA class >= III, previously documented EF < 30%
- severe aortic regurgitation
- anticipated ICU stay < 24 hrs
- not expected to require dialysis > 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Currently, decisions regarding volume management for dialysis sessions in the ICU are made in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume status using devices such as the Crit-Line™ III, and central venous pressures. However, these tools perform poorly in predicting the circulatory system's overall response to dialysis. Consequently, episodes of dangerously low blood pressure are still frequently encountered. Better techniques to predict the circulatory system's response to dialysis are much needed. The intent of this study is to test newer metrics of circulatory system function for their ability to predict low blood pressure episodes during dialysis. This is important because it may enable the design of newer treatment strategies created to prevent low blood pressure episodes during dialysis and improve patient outcomes. The investigators overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid responsiveness, previously found to better reflect cardiac preload state than currently used parameters, will better predict low blood pressure episodes during dialysis than current methods.
- Conditions
- Peridialytic Hypotension
- Being tested
- Transpulmonary Thermodilution
- Keywords
- hemodialysis, dialysis, hypotension, CritLine, PiCCO, Thermodilution, CVVHDF, IHD
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpulmonary ThermodilutionProcedure or surgery
Also called Pulsion Medical Systems, PiCCO2, PiCCO
A PiCCO femoral catheter will be placed and PiCCO parameters will be obtained using transpulmonary thermodilution after continuous dialysis is ordered or just prior to initiation of intermittent dialysis, hourly until either completion of intermittent dialysis or 8 hours of continuous dialysis is completed.
| Study group | Role | What they receive |
|---|---|---|
| ICU Dialysis Patients | Any patient 18 years and older who is admitted to the OHSU Hospitals ICUs with ARF, or End Stage Renal Disease (ESRD) for a diagnosis other than hyperkalemia, as the sole determinant for that level of care, will be invited to participate. The patient must have acute or chronic needs for dialytic support during their ICU stay. Receives: Procedure: Transpulmonary Thermodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotensive episode
A mean arterial pressure of <60 mmHg, a 15% decrease from baseline systolic blood pressure at the start of the dialysis treatment regardless of modality, the need for fluid bolusing >7 mL/kg body weight, or initiation or increase of vasopressor medication in order to maintain MAP >60 mmHg.
Measured: during or within one hour post dialysis
Secondary outcomes (6)
fluid removal tolerance
Parameters measured will be examined to discriminate between patients that will tolerate fluid removal (UF) during the following 4 hours of dialysis if UF is ordered by physician (no hypotensive events with > 500 mL fluid removal) from those that won't
Measured: during the 4 hours following parameter measurement in dialysis
predicted volume of fluid that can be removed without hypotensive events
Parameters measured will be examined to see if they can predict the volume of fluid successfully removed without hypotensive events
Measured: during dialysis
mortality in the ICU
Measured: duration of ICU stay
All cause mortality
Measured: 30 days
Length of stay in ICU
Measured: ICU stay duration
Length of stay in hospital
Measured: duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study start19 Jul 2010
- Primary completion11 Mar 2013
- Study completion11 Mar 2013
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Peridialytic HypotensionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles R Phillips, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171352
- Sponsor's protocol ID
- IRB00006189
- Status last verified
- Jun 2019
- First submitted
- 27 Jul 2010
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
U.S. Renal Data System, USRDS 2008 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. In: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; 2008.
Higgins TL, Teres D, Copes WS, Nathanson BH, Stark M, Kramer AA. Assessing contemporary intensive care unit outcome: an updated Mortality Probability Admission Model (MPM0-III). Crit Care Med. 2007 Mar;35(3):827-35. doi: 10.1097/01.CCM.0000257337.63529.9F.
PubMed 17255863Rocha E, Soares M, Valente C, Nogueira L, Bonomo H Jr, Godinho M, Ismael M, Valenca RV, Machado JE, Maccariello E. Outcomes of critically ill patients with acute kidney injury and end-stage renal disease requiring renal replacement therapy: a case-control study. Nephrol Dial Transplant. 2009 Jun;24(6):1925-30. doi: 10.1093/ndt/gfn750. Epub 2009 Jan 22.
PubMed 19164319Uchino S, Morimatsu H, Bellomo R, Silvester W, Cole L. End-stage renal failure patients requiring renal replacement therapy in the intensive care unit: incidence, clinical features, and outcome. Blood Purif. 2003;21(2):170-5. doi: 10.1159/000069156.
PubMed 12601260Daugirdas JT. Pathophysiology of dialysis hypotension: an update. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S11-7. doi: 10.1053/ajkd.2001.28090.
PubMed 11602456Goedje O, Seebauer T, Peyerl M, Pfeiffer UJ, Reichart B. Hemodynamic monitoring by double-indicator dilution technique in patients after orthotopic heart transplantation. Chest. 2000 Sep;118(3):775-81. doi: 10.1378/chest.118.3.775.
PubMed 10988202Krepel HP, Nette RW, Akcahuseyin E, Weimar W, Zietse R. Variability of relative blood volume during haemodialysis. Nephrol Dial Transplant. 2000 May;15(5):673-9. doi: 10.1093/ndt/15.5.673.
PubMed 10809809Davenport A. Can advances in hemodialysis machine technology prevent intradialytic hypotension? Semin Dial. 2009 May-Jun;22(3):231-6. doi: 10.1111/j.1525-139X.2009.00614.x.
PubMed 19572996Sakka SG, Reinhart K, Meier-Hellmann A. Comparison of pulmonary artery and arterial thermodilution cardiac output in critically ill patients. Intensive Care Med. 1999 Aug;25(8):843-6. doi: 10.1007/s001340050962.
PubMed 10447543Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
PubMed 14605066Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
PubMed 12065368Phillips CR, Watters JM, Hagg DS, et al. Global end-diastolic volume as an indicator of cardiac preload in hemorrhagic shock and resuscitation in swine. Critical Care 2008;12(Suppl 2):P104.
Phillips CR, Vinecore K, Hagg DS, Sawai RS, Differding JA, Watters JM, Schreiber MA. Resuscitation of haemorrhagic shock with normal saline vs. lactated Ringer's: effects on oxygenation, extravascular lung water and haemodynamics. Crit Care. 2009;13(2):R30. doi: 10.1186/cc7736. Epub 2009 Mar 4.
PubMed 19257901Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8. doi: 10.1164/ajrccm.162.1.9903035.
PubMed 10903232De Backer D, Heenen S, Piagnerelli M, Koch M, Vincent JL. Pulse pressure variations to predict fluid responsiveness: influence of tidal volume. Intensive Care Med. 2005 Apr;31(4):517-23. doi: 10.1007/s00134-005-2586-4. Epub 2005 Mar 8.
PubMed 15754196
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Hypotension During Dialysis in the ICU
- ClinicalTrials.gov ID
- NCT01171352
- Acronym / sponsor ID
- IRB00006189
- Conditions
- Peridialytic Hypotension
- Keywords
- hemodialysis, dialysis, hypotension, CritLine, PiCCO, Thermodilution, CVVHDF, IHD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 19 Jul 2010 (actual)
- Primary completion
- 11 Mar 2013 (actual)
- Study completion
- 11 Mar 2013 (actual)
- First posted
- 28 Jul 2010 (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.
Currently, decisions regarding volume management for dialysis sessions in the ICU are made in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume status using devices such as the Crit-Line™ III, and central venous pressures. However, these tools perform poorly in predicting the circulatory system's overall response to dialysis. Consequently, episodes of dangerously low blood pressure are still frequently encountered. Better techniques to predict the circulatory system's response to dialysis are much needed. The intent of this study is to test newer metrics of circulatory system function for their ability to predict low blood pressure episodes during dialysis. This is important because it may enable the design of newer treatment strategies created to prevent low blood pressure episodes during dialysis and improve patient outcomes. The investigators overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid responsiveness, previously found to better reflect cardiac preload state than currently used parameters, will better predict low blood pressure episodes during dialysis than current methods.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Dialysis Patients | – | Procedure: Transpulmonary ThermodilutionAny patient 18 years and older who is admitted to the OHSU Hospitals ICUs with ARF, or End Stage Renal Disease (ESRD) for a diagnosis other than hyperkalemia, as the sole determinant for that level of care, will be invited to participate. The patient must have acute or chronic needs for dialytic support during their ICU stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient 18 years and older who is admitted to the OHSU Hospitals ICUs with ARF, or End Stage Renal Disease (ESRD) for a diagnosis other than hyperkalemia, as the sole determinant for that level of care, will be invited to participate. The patient must have acute or chronic needs for dialytic support during their ICU stay in order to qualify for the study. Dialysis support may be provided by intermittent HD sessions, or continuous venovenous hemodiafiltration (CVVHDF) depending on the underlying hemodynamic stability of the patient.
Key inclusion criteria (4 listed)
- Admitted to OHSU Hospitals ICUs
- Patient has acute or chronic needs for intermittent hemodialysis support during their ICU stay for any reason other than isolated hyperkalemia
- Central venous access in place separate from the dialysis catheter, or arteriovenous fistula or graft
- Two or more organ systems affected by critical illness requiring supportive care as documented in the medical chart.
Key exclusion criteria (13 listed)
- age younger than 18 years old
- Weight > 160 kg
- burns greater than 40% total body surface area
- known cardiac or vascular aneurysm
- contraindications to femoral arterial puncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transpulmonary ThermodilutionAlso: Pulsion Medical Systems, PiCCO2, PiCCOA PiCCO femoral catheter will be placed and PiCCO parameters will be obtained using transpulmonary thermodilution after continuous dialysis is ordered or just prior to initiation of intermittent dialysis, hourly until either completion of intermittent dialysis or 8 hours of continuous dialysis is completed. | Procedure or surgery | ICU Dialysis Patients |
Primary outcome
hypotensive episode
Time frame: during or within one hour post dialysis
A mean arterial pressure of <60 mmHg, a 15% decrease from baseline systolic blood pressure at the start of the dialysis treatment regardless of modality, the need for fluid bolusing >7 mL/kg body weight, or initiation or increase of vasopressor medication in order to maintain MAP >60 mmHg.
6 secondary outcomes
fluid removal tolerance
Time frame: during the 4 hours following parameter measurement in dialysis
predicted volume of fluid that can be removed without hypotensive events
Time frame: during dialysis
mortality in the ICU
Time frame: duration of ICU stay
All cause mortality
Time frame: 30 days
Length of stay in ICU
Time frame: ICU stay duration
Length of stay in hospital
Time frame: duration of hospital stay
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 5 Jun 2019.
- BackgroundU.S. Renal Data System, USRDS 2008 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. In: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; 2008.
- Background: PubMed 17255863Higgins TL, Teres D, Copes WS, Nathanson BH, Stark M, Kramer AA. Assessing contemporary intensive care unit outcome: an updated Mortality Probability Admission Model (MPM0-III). Crit Care Med. 2007 Mar;35(3):827-35. doi: 10.1097/01.CCM.0000257337.63529.9F.
- Background: PubMed 19164319Rocha E, Soares M, Valente C, Nogueira L, Bonomo H Jr, Godinho M, Ismael M, Valenca RV, Machado JE, Maccariello E. Outcomes of critically ill patients with acute kidney injury and end-stage renal disease requiring renal replacement therapy: a case-control study. Nephrol Dial Transplant. 2009 Jun;24(6):1925-30. doi: 10.1093/ndt/gfn750. Epub 2009 Jan 22.
- Background: PubMed 12601260Uchino S, Morimatsu H, Bellomo R, Silvester W, Cole L. End-stage renal failure patients requiring renal replacement therapy in the intensive care unit: incidence, clinical features, and outcome. Blood Purif. 2003;21(2):170-5. doi: 10.1159/000069156.
- Background: PubMed 11602456Daugirdas JT. Pathophysiology of dialysis hypotension: an update. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S11-7. doi: 10.1053/ajkd.2001.28090.
- Background: PubMed 10988202Goedje O, Seebauer T, Peyerl M, Pfeiffer UJ, Reichart B. Hemodynamic monitoring by double-indicator dilution technique in patients after orthotopic heart transplantation. Chest. 2000 Sep;118(3):775-81. doi: 10.1378/chest.118.3.775.
- Background: PubMed 10809809Krepel HP, Nette RW, Akcahuseyin E, Weimar W, Zietse R. Variability of relative blood volume during haemodialysis. Nephrol Dial Transplant. 2000 May;15(5):673-9. doi: 10.1093/ndt/15.5.673.
- Background: PubMed 19572996Davenport A. Can advances in hemodialysis machine technology prevent intradialytic hypotension? Semin Dial. 2009 May-Jun;22(3):231-6. doi: 10.1111/j.1525-139X.2009.00614.x.
- Background: PubMed 10447543Sakka SG, Reinhart K, Meier-Hellmann A. Comparison of pulmonary artery and arterial thermodilution cardiac output in critically ill patients. Intensive Care Med. 1999 Aug;25(8):843-6. doi: 10.1007/s001340050962.
- Background: PubMed 14605066Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
- Background: PubMed 12065368Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
- BackgroundPhillips CR, Watters JM, Hagg DS, et al. Global end-diastolic volume as an indicator of cardiac preload in hemorrhagic shock and resuscitation in swine. Critical Care 2008;12(Suppl 2):P104.
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.
Charles R Phillips, MD principal investigator
Oregon Health and Science University
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 Peridialytic Hypotension, run by Oregon Health and Science University 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 13 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 5 Jun 2019. 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?
hypotensive episode (time frame: during or within one hour post dialysis). 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 NCT01171352, which also lists 16 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 5 Jun 2019.