Predicting Hypotension During Dialysis in the ICU

Withdrawn

• Conditions: Peridialytic Hypotension
• Interventions: Procedure: Transpulmonary Thermodilution

• Registration Number: NCT01171352
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-19
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Primary Completion: 2013-03-11
• Study Completion: 2013-03-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU Dialysis Patients	Transpulmonary Thermodilution	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.

Primary Outcome Measures

Name	Time	Method
hypotensive episode	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.

Secondary Outcome Measures

Name	Time	Method
fluid removal tolerance	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
predicted volume of fluid that can be removed without hypotensive events	during dialysis	Parameters measured will be examined to see if they can predict the volume of fluid successfully removed without hypotensive events
mortality in the ICU	duration of ICU stay
All cause mortality	30 days
Length of stay in ICU	ICU stay duration
Length of stay in hospital	duration of hospital stay

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States