Predicting Hypotension During Dialysis in the ICU

NCT ID: NCT01171352

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-19

Study Completion Date

2013-03-11

Brief Summary

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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.

Detailed Description

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Conditions

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Peridialytic Hypotension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Transpulmonary Thermodilution

Intervention Type PROCEDURE

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.

Interventions

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Transpulmonary Thermodilution

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.

Intervention Type PROCEDURE

Other Intervention Names

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Pulsion Medical Systems PiCCO2 PiCCO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles R Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17255863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19164319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12601260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11602456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10988202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10809809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19572996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10447543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14605066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12065368 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19257901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10903232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15754196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15930095 (View on PubMed)

Other Identifiers

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IRB00006189

Identifier Type: -

Identifier Source: org_study_id

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