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Predicting Hypotension During Dialysis in the ICU

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01171352
First received: July 27, 2010
Last updated: March 3, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention
Peridialytic Hypotension
Procedure: Transpulmonary Thermodilution

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predicting Hypotension During Dialysis in the ICU

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • hypotensive episode [ Time Frame: during or within one hour post dialysis ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • fluid removal tolerance [ Time Frame: during the 4 hours following parameter measurement in dialysis ] [ Designated as safety issue: No ]
    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

  • predicted volume of fluid that can be removed without hypotensive events [ Time Frame: during dialysis ] [ Designated as safety issue: No ]
    Parameters measured will be examined to see if they can predict the volume of fluid successfully removed without hypotensive events

  • mortality in the ICU [ Time Frame: duration of ICU stay ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of stay in ICU [ Time Frame: ICU stay duration ] [ Designated as safety issue: No ]
  • Length of stay in hospital [ Time Frame: duration of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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:
  • Pulsion Medical Systems
  • PiCCO2
  • PiCCO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171352

Contacts
Contact: Samantha S Ruimy, MSIS 503-494-0724 ruimy@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Charles R Phillips, MD    503-494-2465    phillipc@ohsu.edu   
Contact: Suppriya Maddirala, MD    5034947653    maddiral@ohsu.edu   
Principal Investigator: Charles R Phillips, MD         
Sub-Investigator: Suppriya Maddirala, MD         
Sub-Investigator: Akram Khan, MD         
Sub-Investigator: Ryan Griffiths, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Charles R Phillips, MD Oregon Health and Science University
  More Information

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.
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.

Responsible Party: Assistant Professor Charles Phillips, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01171352     History of Changes
Other Study ID Numbers: IRB00006189
Study First Received: July 27, 2010
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
hemodialysis
dialysis
hypotension
CritLine
PiCCO
Thermodilution
CVVHDF
IHD

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014