Starling/CRRT Observational Study

NCT05729048 | Withdrawn

• 1 other identifier: BXU578332
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (13)

• 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

  Day 1 (during CRRT)

• Changes in hourly/daily fluid balance during CRRT

  Day 1 (during CRRT)

Study Arms (1)

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

Interventions

Starling DEVICE

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.

Hemodynamic Monitoring

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Baxter Investigational Site

Lexington, Kentucky, 40506, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: February 15, 2023
• Study Start: July 15, 2023
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon approval of a legitimate research request.
• 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.

Locations

US (1)