Predicting Hypotension During Dialysis in the ICU
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Predicting Hypotension During Dialysis in the ICU|
- 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.
- 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 ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171352
|Contact: Samantha S Ruimy, MSISfirstname.lastname@example.org|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Charles R Phillips, MD 503-494-2465 email@example.com|
|Contact: Suppriya Maddirala, MD 5034947653 firstname.lastname@example.org|
|Principal Investigator: Charles R Phillips, MD|
|Sub-Investigator: Suppriya Maddirala, MD|
|Sub-Investigator: Akram Khan, MD|
|Sub-Investigator: Ryan Griffiths, MD|
|Principal Investigator:||Charles R Phillips, MD||Oregon Health and Science University|