Predicting Hypotension During Dialysis in the ICU

NCT01171352 | Withdrawn

• 1 other identifier: IRB00006189
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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, 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

Keywords

hemodialysis; dialysis; hypotension; CritLine; PiCCO; Thermodilution; CVVHDF; IHD

Outcome Measures

Primary Outcomes (1)

• 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.

  during or within one hour post dialysis

Secondary Outcomes (6)

• fluid removal tolerance

  during the 4 hours following parameter measurement in dialysis

• predicted volume of fluid that can be removed without hypotensive events

  during dialysis

• mortality in the ICU

  duration of ICU stay

• All cause mortality

  30 days

• Length of stay in ICU

  ICU stay duration

Study Arms (1)

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.

Procedure: Transpulmonary Thermodilution

Interventions

Transpulmonary Thermodilution 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.

Also known as: Pulsion Medical Systems, PiCCO2, PiCCO

ICU Dialysis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (16)

• 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.

  BACKGROUND

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  PMID: 19164319 BACKGROUND

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  PMID: 12601260 BACKGROUND

• 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.

  PMID: 11602456 BACKGROUND

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  PMID: 10988202 BACKGROUND

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  PMID: 10809809 BACKGROUND

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  PMID: 19572996 BACKGROUND

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  PMID: 10447543 BACKGROUND

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  PMID: 14605066 BACKGROUND

• 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.

  PMID: 12065368 BACKGROUND

• 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.

  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.

  PMID: 19257901 BACKGROUND

• 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.

  PMID: 10903232 BACKGROUND

• 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.

  PMID: 15754196 BACKGROUND

• 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.

  PMID: 15930095 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charles R Phillips, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: July 19, 2010
• Primary Completion: March 11, 2013
• Study Completion: March 11, 2013
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

US (1)