Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02837731
Other study ID # PRO-OOO1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date March 13, 2019

Study information

Verified date November 2020
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.


Description:

Multi-center randomized study comparing dynamic assessment of fluid responsiveness utilizing Starling SV monitor compared to a control group. Subjects will be randomized in a 2:1 treatment to control group ratio to increase power for sub-analysis by patient population. Patients randomized to the Starling SV arm will have treatment guided by a dynamic assessment of fluid responsiveness (measured by a change in stroke volume index > 10%) as assessed by passive leg raise (PLR). Patients randomized to the control group will receive standard of care treatment.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 13, 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of sepsis, as exhibited by 2 or more of the following systemic inflammatory response syndrome (SIRS) criteria and a known or presumed infection at time of screening: - Temperature of > 38 C or < 36 C - Heart rate of > 90/min - Respiratory rate of > 20/min or PaCO2 < 32 mm Hg (4.3 kPA) - White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands 2. Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid) 3. Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital 4. Anticipated ICU admission 5. Able to provide signed informed consent or consent can be obtained from the patient's authorized representative Exclusion Criteria: 1. Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, or injury from burn or trauma 2. Known aortic insufficiency, or aortic abnormalities 3. Hemodynamic instability due to active gastrointestinal hemorrhage 4. Patient has received >3 liters of IV fluid prior to study randomization 5. Requires immediate surgery 6. Patient transferred to the ICU from another hospital unit 7. Do not attempt resuscitation (DNAR or DNR) order 8. Advanced directives restricting implementation of the resuscitation protocol 9. Contraindication to blood transfusion 10. Attending clinician deems aggressive resuscitation unsuitable 11. Transferred from another in-hospital setting 12. Not able to commence treatment protocol within 1 hour after randomization 13. Known intraventricular heart defect, such as ventral septal defect or atrial septal defect 14. Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness 15. Seizure in the last 24 hours 16. Prisoner 17. Pregnancy 18. Age <18 19. Known allergy to sensor material or gel 20. Inability or contraindication to doing a passive leg raise with both extremities, such as inability to interrupt venous compression boots 21. Patient has an epidural catheter in place 22. Suspected intra-abdominal hypertension 23. Inability to obtain IV access 24. Diabetic ketoacidosis 25. Hyper-osmolarity syndrome 26. Patient uncouples from treatment algorithm 27. Patient should be excluded based on the opinion of the Clinician/Investigator

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Treatment Starling SV monitor
A dynamic assessment of fluid responsiveness will be performed at every clinical decision point for the first 72 hours of study enrollment. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.

Locations

Country Name City State
United Kingdom Royal Surrey County Hospital Guildford
United States Grady Memorial Hospital Atlanta Georgia
United States Ohio State University Hospital Columbus Ohio
United States Denver Health Denver Colorado
United States Baylor College of Medicine Houston Texas
United States Indiana University Methodist Hospital Indianapolis Indiana
United States Vanderbilt University Medical Center Nashville Tennessee
United States New York Presbyterian Brooklyn Methodist Hospital New York New York
United States NYU School of Medicine New York New York
United States Oregon Health and Science University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States University of California San Francisco Medical Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Cheetah Medical Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Volume of Fluid Traditional methods of assessing fluid responsiveness (FR) such as vital signs, physical examination, and static measurements of circulatory pressure have shown not to reliably correlate with fluid responsiveness. In contrast, dynamic measurement of stroke volume (SV) following an intravenous (IV) fluid bolus or passive leg raise (PLR) is a safe and feasible method of rapidly assessing the effectiveness of fluid-induced augmentation of SV and cardiac output (CO). Mean volume of treatment fluid Administered (ml) at 72 hours or ICU discharge, whichever occurs first, between the two treatment groups 72 hours
Other Percentage of Participants With Major Adverse Cardiac Event (MACE) Incidence of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. Day 1 to Day 30
Other Number of Participants Experiencing an Adverse Event (AE) Related to Study Device Adverse events associated with the treatment procedure. Day 1 to Day 30
Other Percentage of Participants With Hospital Discharge Without ICU Readmission Day 1 to Day 30
Other Percentage of Participants Within Overall 30 Day Mortality Rate Incidence of death. Day 1 to Day 30
Other Number of Participants by Hospital Discharge Location Patient location (either "home" or "other") following hospital discharge. Day 1 to Day 30
Primary Fluid Balance Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments. 72 hours
Secondary Percentage of Participants Requiring Renal Replacement Therapy Renal replacement therapy (RRT) is therapy that replaces the normal blood-filtering function of the kidneys. It is used when the kidneys are not working well, which is called kidney failure and includes acute kidney injury and chronic kidney disease. Patient receives new treatment with dialysis. Day 1 to Day 30
Secondary Percentage of Participants Requiring Ventilator Use Patients did not enter the study on ventilation, but required ventilator use during the study are included in the analysis. Day 1 to Day 30
Secondary Length of ICU Stay Intensive Car Unit (ICU) length of stay will be calculated using the earliest of date that the subject is medically ready for discharge when captured, the date of discharge, or the study exit date. Day 1 to Day 30
Secondary Number of Hours of Ventilator Use Patients that did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support). Day 1 to Day 30
Secondary Number of Hours of Vasopressor Use Vasopressor drugs are provided to restore and maintain blood pressure in patients with septic shock. Patients that have vasopressors initiated throughout the trial are included in this analysis. Day 1 to Day 30
Secondary Change From Baseline in Serum Creatinine Levels at 72 Hours The diagnosis of Acute Kidney Injury (AKI) is traditionally based on a rise in serum creatinine Baseline, 72 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3