Starling/CRRT Observational Study

Study Overview
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Brief Summary
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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.

Official Title
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Starling Continuous Renal Replacement Therapy (CRRT) Observational Study

Conditions
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Hemodynamic Monitoring

Intervention / Treatment
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* Device: Starling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 to 95 years of age. Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment. Hemodynamic monitoring was completed no earlier than 2018 Exclusion Criteria: Patients did not have an arterial line in place during CRRT treatment Patients on extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) Patients with end-stage kidney disease on chronic dialysis Hemodynamic monitoring with Starling did not occur during CRRT treatment Data from Starling, CRRT machine, or arterial line cannot be retrieved

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodynamic Monitoring<br>Over the course of a patient's hospitalization, data will be collected on patients from the initiation to completion of hemodynamic monitoring with the Starling monitor during CRRT treatment. | Device: Starling<br>* Starling is a portable, non-invasive, cardiac output detector system. The Starling monitor measures the cardiac output by employing electrical bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. The Starling electrode is a double electrode sensor. Within each sensor, one electrode is used to transmit a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. This information is used to determine cardiac output. The Starling monitor also measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling monitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stroke volume (SV) after CRRT initiation |  | Day 1 (during CRRT) | 
| Change in cardiac output (CO) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in cardiac index (CI) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in stroke volume (SV) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in stroke volume index (SVI) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in Thoracic Fluid Content (TFC) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in heart rate (HR) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in systolic blood pressure (SBP) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in diastolic blood pressure (DBP) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in central venous pressure (CVP) after fluid removal | Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in mixed venous oxygen saturation (SVO2) after fluid removal | Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Change in lactate after fluid removal | Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h) | Day 1 (during CRRT) | 
| Changes in systolic blood pressure (SBP) from beginning to end of CRRT |  | Day 1 (Begin CRRT) through Day 1 (End of CRRT) | 
| Changes in diastolic blood pressure (DBP) from beginning to end of CRRT |  | Day 1 (Begin CRRT) through Day 1 (End of CRRT) | 
| Changes in mean arterial pressure (MAP) from beginning to end of CRRT |  | Day 1 (Begin CRRT) through Day 1 (End of CRRT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intradialytic hypotension (IDH) during CRRT |  | Day 1 (during CRRT) | 
| Incidence of intradialytic hypotension (IDH) free time during CRRT |  | Day 1 (during CRRT) | 
| Incidence of time to resolution in intradialytic hypotension (IDH) during CRRT |  | Day 1 (during CRRT) | 
| Changes in intake and output (I/O) during CRRT | Fluid balance parameter | Day 1 (during CRRT) | 
| Changes in hourly/daily fluid balance during CRRT |  | Day 1 (during CRRT) | 
| Changes in cumulative fluid balance during CRRT |  | Day 1 (during CRRT) | 
| Changes in percent fluid overload during CRRT | Fluid balance parameter | Day 1 (during CRRT) | 
| Changes in ultrafiltration parameters and net ultrafiltration (UFnet) during CRRT |  | Day 1 (during CRRT) | 
| Incidence of ultrafiltration failure during CRRT | Including prescribed/archived, time to fluid balance | Day 1 (during CRRT) | 
| Blood flow rate during CRRT |  | Day 1 (during CRRT) | 
| CRRT dose/modality |  | Day 1 (during CRRT) | 
| Estimate the contribution degree of certain patient conditions, clinical characteristics, fluid, and CRRT parameters in predicting the IDH risk during CRRT |  | Day 1 (during CRRT) | 
| Identify sub-phenotypes of patients at risk of IDH during CRRT |  | Day 1 (during CRRT) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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