The primary objective of this study is to evaluate the personalized hemodynamic resuscitation protocol, guided by the Baxter Starling, for sepsis patients within the first six hours after admission to the emergency department, in comparison to the…
ID
Source
Brief title
Condition
- Other condition
- Infections - pathogen unspecified
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Health condition
sepsis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point is the volume (in Liters) of I.V. fluid resuscitation at
six hours since ED admission.
Secondary outcome
Secondary end points include efficacy (a.o. hospital admission, length-of-stay,
new onset organ failure), safety (a.o. adverse events, mortality),
health-technology (a.o. cost-effectiveness) and exploratory mechanistic
parameters.
Background summary
Sepsis is a life-threatening condition characterized by organ dysfunction
resulting from an uncontrolled host response to infection. The
pathophysiological changes in sepsis affect both micro- and macrovascular
components, necessitating early hemodynamic resuscitation to prevent organ
failure and death. However, the current one-size-fits-all approach may lead to
prolonged shock or fluid overload with its complications. The Starling SV
monitor, which provides real-time cardiac output and total peripheral
resistance measurements, has the potential to guide personalized resuscitation
for sepsis patients. The objective of this study is to evaluate the
personalized hemodynamic resuscitation protocol, guided by the Baxter Starling,
for sepsis patients within the first six hours after admission to the emergency
department, in comparison to the existing treatment protocol.
Study objective
The primary objective of this study is to evaluate the personalized hemodynamic
resuscitation protocol, guided by the Baxter Starling, for sepsis patients
within the first six hours after admission to the emergency department, in
comparison to the existing treatment protocol. By focusing on patients admitted
to the emergency department, the study has the potential to revolutionize the
management of sepsis, improve outcomes, and enhance patient care in this
life-threatening condition.
Study design
This is a randomized open clinical trial. Adult patients with suspected
infection at the ED will be recruited and randomly assigned to either
personalized hemodynamic resuscitation using the Starling SV monitor
(intervention group) or standard care (control group). The trial will span 16
months, and a total of 174 patients will be included.
Intervention
In the experimental arm, personalized hemodynamic resuscitation will be guided
by the Starling SV monitor, with fluid responsiveness assessed using passive
leg raise and subsequent fluid boluses administered based on the increase in
cardiac output. The control arm will receive standard care determined by the
treating physician.
Study burden and risks
In this intervention study, the utilization of the Starling SV monitor provides
significant benefits for sepsis patients in the ED. By tailoring treatment
plans to individual hemodynamic changes, patients receive precise fluid
administration and timely initiation of vasopressor therapy, reducing the risks
of prolonged hypotension and fluid overload. This personalized approach has the
potential to optimize sepsis management. Although there are minimal risks
associated with the monitor, such as minimal adverse events and the potential
for device malfunction or misinterpretation of readings, proper training,
adherence to protocols, and regular evaluation can mitigate these risks and
ensure patient safety. Overall, the benefits of the Starling SV monitor
outweigh its risks, making it a valuable tool in improving patient outcomes.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Adult patients (>= 18 years of age);**
• Referred to internal medicine, nephrology, geriatric medicine, oncology,
hematology, lung medicine, rheumatology, gastrointestinal / liver medicine,
urology, or emergency medicine (non-trauma);**
• Confirmed or suspected infection according to the physician*s judgement upon
arrival to the ED, based the presence of an acute phase response not due to an
alternative non-infectious cause (i.e., body temperature < 36°C or >38°C,
leukocyte count > 12 x10^9/L or C-reactive protein > 50 mg/L), and/or on
symptoms suggestive for an infection (e.g. productive cough, dyspnea, dysuria,
pollakisuria, abdominal pain, erythema)
• Need for hemodynamic resuscitation, based on any of the following (first
measurement pre-hospital or at ED arrival):
o Mean arterial pressure (MAP) < 70 mmHg
o Systolic blood pressure (SBP) < 90 mmHg or a SBP decrease >40 mmHg
o Lactate > 4.0 mmol/L
o Shock index* > 0.9
• Enrolled in study within one hour after ED arrival
* Shock index is heart rate divided by systolic blood pressure
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• 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, diabetic ketoacidosis,
hyper-osmolarity syndrome, pancreatitis
• Known aortic insufficiency, aortic abnormalities, or intraventricular heart
defect, such as ventral septal defect or atrial septal defect
• Known advanced heart failure - meaning NYHA IV functional class HF, on
waiting list for heart transplant, LVAD recipient or chronic inotrope use.
• Hemodynamic instability due to active bleeding
• Patient has received >1 liter of I.V. fluid prior to study randomization
• Requires immediate surgery
• Transfer from another hospital after initiation of therapy (a.o. referred by
another hospital ICU)*or another in-hospital setting
• Pregnant women**
• Trauma patients*
• Known major lower extremity amputation (proximal to the ankle joint)
• Suspected intra-abdominal hypertension, based on the presence of portal
hypertension (i.e. presence of ascites due to liver cirrhosis, esophageal
varices or as measured by Doppler ultrasound before or despite TIPS or liver
transplantation)
• Inability to obtain IV access
• Patient uncouples from treatment algorithm
• Patient should be excluded based on the opinion of the Clinician/Investigator
• Not able to commence treatment protocol within 1 hour after randomization
• Potential ICU-admission unwanted by advanced care directive (e.g., limited
life expectancy)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84833.099.24 |