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Predicting Hypotension During Dialysis in the ICU

Predicting Hypotension During Dialysis in the ICU

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01171352
Enrollment
0
Registered
2010-07-28
Start date
2010-07-19
Completion date
2013-03-11
Last updated
2019-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peridialytic Hypotension

Keywords

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

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.

Interventions

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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hypotensive episodeduring or within one hour post dialysisA 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

MeasureTime frameDescription
predicted volume of fluid that can be removed without hypotensive eventsduring dialysisParameters measured will be examined to see if they can predict the volume of fluid successfully removed without hypotensive events
mortality in the ICUduration of ICU stay
fluid removal toleranceduring the 4 hours following parameter measurement in dialysisParameters 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
Length of stay in ICUICU stay duration
Length of stay in hospitalduration of hospital stay
All cause mortality30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026