Starling/CRRT Observational Study

Hemodynamic Monitoring Clinical Trial

Official title:

Starling Continuous Renal Replacement Therapy (CRRT) Observational Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05729048
• Other study ID #: BXU578332
• Status: Withdrawn
• Start date: July 15, 2023
• Est. completion date: March 14, 2025

Study information

• Verified date: July 2023
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 14, 2025
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Monitoring

Intervention

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.

Locations

Country	Name	City	State
United States	Baxter Investigational Site	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stroke volume (SV) after CRRT initiation		Day 1 (during CRRT)
Primary	Change in cardiac output (CO) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in cardiac index (CI) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in stroke volume (SV) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in stroke volume index (SVI) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in Thoracic Fluid Content (TFC) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in heart rate (HR) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in systolic blood pressure (SBP) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in diastolic blood pressure (DBP) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in central venous pressure (CVP) after fluid removal	Cardiac physiology adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in mixed venous oxygen saturation (SVO2) after fluid removal	Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Change in lactate after fluid removal	Perfusion parameter adjusted to net ultrafiltration intensities (ml/kg/h)	Day 1 (during CRRT)
Primary	Changes in systolic blood pressure (SBP) from beginning to end of CRRT		Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Primary	Changes in diastolic blood pressure (DBP) from beginning to end of CRRT		Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Primary	Changes in mean arterial pressure (MAP) from beginning to end of CRRT		Day 1 (Begin CRRT) through Day 1 (End of CRRT)
Secondary	Incidence of intradialytic hypotension (IDH) during CRRT		Day 1 (during CRRT)
Secondary	Incidence of intradialytic hypotension (IDH) free time during CRRT		Day 1 (during CRRT)
Secondary	Incidence of time to resolution in intradialytic hypotension (IDH) during CRRT		Day 1 (during CRRT)
Secondary	Changes in intake and output (I/O) during CRRT	Fluid balance parameter	Day 1 (during CRRT)
Secondary	Changes in hourly/daily fluid balance during CRRT		Day 1 (during CRRT)
Secondary	Changes in cumulative fluid balance during CRRT		Day 1 (during CRRT)
Secondary	Changes in percent fluid overload during CRRT	Fluid balance parameter	Day 1 (during CRRT)
Secondary	Changes in ultrafiltration parameters and net ultrafiltration (UFnet) during CRRT		Day 1 (during CRRT)
Secondary	Incidence of ultrafiltration failure during CRRT	Including prescribed/archived, time to fluid balance	Day 1 (during CRRT)
Secondary	Blood flow rate during CRRT		Day 1 (during CRRT)
Secondary	CRRT dose/modality		Day 1 (during CRRT)
Secondary	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)
Secondary	Identify sub-phenotypes of patients at risk of IDH during CRRT		Day 1 (during CRRT)