Clinical trial NCT05729048: Starling/CRRT Observational Study
Official title: Starling Continuous Renal Replacement Therapy (CRRT) Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemodynamic Monitoring
Keywords: Cardiac Index (CI)
Stroke Volume (SV)
Stroke Volume Index (SVI)
Stroke Volume Variation (SVV)
Heart Rate (HR)
Ventricular Ejection Time (VET)
Total Peripheral Resistance (TPR)
Total Peripheral Resistance Index (TPRI)
Cardiac Power (CP)
Cardiac Power Index (CPI)
Blood Oxygenation (SPO2)
Oxygen Delivery Index (DO2I)
Electrical impedance of the chest cavity (Z0)
Thoracic Fluid Content (TFC)
Thoracic Fluid Content change from preset time period (TFCd)
Thoracic Fluid Content from baseline (TFCd0)
Changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance® as a result of posture
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population is defined as all patients who meet the study eligibility criteria and have undergone monitoring with the Starling monitor during CRRT. All available data will be included in the analysis.

Brief summary: Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regard to the patient's fluid status and management of additional fluids and medications.

As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management.

This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring during CRRT therapy.


Eligibility criteria: Inclusion Criteria:

1. ≥18 to 95 years of age.
2. Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment.
3. Hemodynamic monitoring was completed no earlier than 2018

Exclusion Criteria:

1. Patients did not have an arterial line in place during CRRT treatment
2. Patients on extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD)
3. Patients with end-stage kidney disease on chronic dialysis
4. Hemodynamic monitoring with Starling did not occur during CRRT treatment
5. Data from Starling, CRRT machine, or arterial line cannot be retrieved

Primary outcomes:
measure: Change in stroke volume (SV) after CRRT initiation
timeFrame: Day 1 (during CRRT)
measure: Change in cardiac output (CO) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in cardiac index (CI) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in stroke volume (SV) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in stroke volume index (SVI) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in Thoracic Fluid Content (TFC) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in heart rate (HR) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in systolic blood pressure (SBP) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in diastolic blood pressure (DBP) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in central venous pressure (CVP) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in mixed venous oxygen saturation (SVO2) after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Change in lactate after fluid removal
timeFrame: Day 1 (during CRRT)
measure: Changes in systolic blood pressure (SBP) from beginning to end of CRRT
timeFrame: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
measure: Changes in diastolic blood pressure (DBP) from beginning to end of CRRT
timeFrame: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
measure: Changes in mean arterial pressure (MAP) from beginning to end of CRRT
timeFrame: Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Secondary outcomes:
measure: Incidence of intradialytic hypotension (IDH) during CRRT
timeFrame: Day 1 (during CRRT)
measure: Incidence of intradialytic hypotension (IDH) free time during CRRT
timeFrame: Day 1 (during CRRT)
measure: Incidence of time to resolution in intradialytic hypotension (IDH) during CRRT
timeFrame: Day 1 (during CRRT)
measure: Changes in intake and output (I/O) during CRRT
timeFrame: Day 1 (during CRRT)
measure: Changes in hourly/daily fluid balance during CRRT
timeFrame: Day 1 (during CRRT)
measure: Changes in cumulative fluid balance during CRRT
timeFrame: Day 1 (during CRRT)
measure: Changes in percent fluid overload during CRRT
timeFrame: Day 1 (during CRRT)
measure: Changes in ultrafiltration parameters and net ultrafiltration (UFnet) during CRRT
timeFrame: Day 1 (during CRRT)
measure: Incidence of ultrafiltration failure during CRRT
timeFrame: Day 1 (during CRRT)
measure: Blood flow rate during CRRT
timeFrame: Day 1 (during CRRT)
measure: CRRT dose/modality
timeFrame: Day 1 (during CRRT)
measure: Estimate the contribution degree of certain patient conditions, clinical characteristics, fluid, and CRRT parameters in predicting the IDH risk during CRRT
timeFrame: Day 1 (during CRRT)
measure: Identify sub-phenotypes of patients at risk of IDH during CRRT
timeFrame: Day 1 (during CRRT)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Baxter Investigational Site
state: Kentucky
Study officials:
References: