Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCopenhagen University Hospital, Hvidovre
About this trial
In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected or documented infection
Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
Serum lactate levels >2 mmol/L
Norepinephrine infusion of > 0.2 mcg/kg/min
Disqualifiers
Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts.
Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability.
Lithium treatment
Treatment with other vasopressor or inotropic drugs.
Trial population
45 adult patients with septic shock according to inclusion criteria admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Hemodynamic measurements during reduction in Norepinephrine and fluid boli.
Drug1. Extended monitoring equipment will be connected to the patient. Clinical and biochemical parameters will be collected for a baseline before the next step. A Safety check will be performed to ensure correct patient data, correct equipment function and safety measures are meet. A passive leg raise test will be performed to predict fluid responsiveness, in case of a positive test, a fluid challenge will be administered. 2. A stepwise reduction of the NE infusion rate from baseline while monitoring stroke volume (SV) to elucidate changes in SV and potential preloadresponsiveness. The reduction will occur in steps of 3-5 minute until either discontinuation of the norepinephrine infusion, a 50% reduction in SV or MAP\<40. 3. While maintaining the NE infusion rate from the previous step 2, a fluid challenge will be administrated, until additional fluid does not increase SV\>10%. 4. As in step 2, a stepwise increase in NE infusion rate to the baseline infusion level or the baseline BP.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Septic Shock1 intervention
Trial outcomes
Primary outcomes
1
Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.
The number of patients who were preload responsive after down-titration of NE.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.
The effect on cardiac output after fluid bolus and subsequent up-titration of NE to the pre-intervention blood pressure target.
Time frame
Through study completion, an average of 1 year2
Microcirculation/perfusion measures during intervention.
The effect of the intervention on measures of tissue perfusion. Different topical sites (Brain, Muscle, Finger, Urethra, Sublingual) by minimal- or noninvasive methods.
Time frame
Through study completion, an average of 1 year3
CO measurement method
Assess the correlation between indirect measurements of CO and lithium dilution measured CO during NE titration.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Copenhagen University Hospital, Hvidovre
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Collaborator
Source ClinicalTrials.gov