- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171352
Predicting Hypotension During Dialysis in the ICU
June 3, 2019 updated by: Oregon Health and Science University
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
during or within one hour post dialysis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: 30 days
|
30 days
|
|
fluid removal tolerance
Time Frame: during the 4 hours following parameter measurement in dialysis
|
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
|
during the 4 hours following parameter measurement in dialysis
|
predicted volume of fluid that can be removed without hypotensive events
Time Frame: during dialysis
|
Parameters measured will be examined to see if they can predict the volume of fluid successfully removed without hypotensive events
|
during dialysis
|
mortality in the ICU
Time Frame: duration of ICU stay
|
duration of ICU stay
|
|
Length of stay in ICU
Time Frame: ICU stay duration
|
ICU stay duration
|
|
Length of stay in hospital
Time Frame: duration of hospital stay
|
duration of hospital stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Charles R Phillips, MD, Oregon Health and Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Michard 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.
- 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.
- Rocha 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.
- Uchino 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.
- Daugirdas 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.
- Goedje 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.
- Krepel 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.
- Davenport 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.
- Sakka 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.
- Michard 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.
- Michard 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.
- Phillips 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.
- De 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.
- Reddan DN, Szczech LA, Hasselblad V, Lowrie EG, Lindsay RM, Himmelfarb J, Toto RD, Stivelman J, Winchester JF, Zillman LA, Califf RM, Owen WF Jr. Intradialytic blood volume monitoring in ambulatory hemodialysis patients: a randomized trial. J Am Soc Nephrol. 2005 Jul;16(7):2162-9. doi: 10.1681/ASN.2004121053. Epub 2005 Jun 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 19, 2010
Primary Completion (Actual)
March 11, 2013
Study Completion (Actual)
March 11, 2013
Study Registration Dates
First Submitted
July 27, 2010
First Submitted That Met QC Criteria
July 27, 2010
First Posted (Estimate)
July 28, 2010
Study Record Updates
Last Update Posted (Actual)
June 5, 2019
Last Update Submitted That Met QC Criteria
June 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00006189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peridialytic Hypotension
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Edwards LifesciencesCompletedHypotension | Intraoperative Hypotension | Postoperative HypotensionNetherlands
-
James J. Peters Veterans Affairs Medical CenterCompleted
-
Attikon HospitalRecruitingHypotension During Surgery | Prevention of HypotensionGreece
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingHypotension Drug-Induced | Hypotension During Surgery
-
Universitätsklinikum Hamburg-EppendorfCompletedBlood Pressure | Postinduction Hypotension | Perioperative HypotensionGermany
-
University of ParmaUnknownHypotension During Dialysis | Dialysis HypotensionItaly
-
Peking Union Medical College HospitalRecruitingPost-induction Hypotension | Postprandial HypotensionChina
-
Seoul National University HospitalCompletedOrthostatic; Hypotension, NeurogenicKorea, Republic of
-
Mazovia Regional Hospital in SiedlceRecruitingAnesthesia | Hypotension on Induction | Perioperative Injury | Perioperative HypotensionPoland
-
Acibadem UniversityCompletedHypotension | Intraoperative Hypotension | Post-induction Hypotension | Post Anesthesia RecoveryTurkey
Clinical Trials on Transpulmonary Thermodilution
-
Fondazione Policlinico Universitario Agostino Gemelli...Antonio Maria Dell Anna; Sofia Cacciola; Claudio Sandroni; Mauro Pittiruti; Cesare... and other collaboratorsCompletedHemodynamic Monitoring | Peripherally Inserted Central Catheters | Transpulmonary Thermodilution | CVCItaly
-
Assistance Publique - Hôpitaux de ParisRecruitingAcute Respiratory Distress SyndromeFrance
-
Bicetre HospitalCompletedCOVID-19 | Shock | Acute Respiratory Distress Syndrome | SARS-CoV-2 | Fluid Overload | Coronavirus | Left Ventricular Dysfunction | Acute Circulatory FailureFrance
-
Karolinska InstitutetRegion StockholmCompletedCardiac Output, Low | Cardiac Output, HighSweden
-
Postgraduate Institute of Medical Education and...CompletedCongenital Heart Disease | Post-Op Complication | Pulmonary CongestionIndia
-
University Hospital, ToulouseCompleted
-
Medisch Spectrum TwenteUnknown
-
Northern State Medical UniversityUniversity of TromsoCompletedValvular Heart DiseaseRussian Federation
-
NYU Langone HealthDaxor CorporationCompletedCovid19 | Bacterial Infections | Acute Respiratory Distress Syndrome | Bacterial SepsisUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Philips HealthcareCompletedCardiac Output, Low | Cardiac Output, HighNetherlands