Starling/CRRT Observational Study

Starling Continuous Renal Replacement Therapy (CRRT) Observational Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Hemodynamic Monitoring
• Intervention / Treatment: Device: Starling

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Baxter Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Hemodynamic Monitoring; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): March 14, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• 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
• Other Study ID Numbers: BXU578332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No