Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

NCT ID: NCT05225402

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2025-12-30

Brief Summary

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.

Conditions

Septic Shock; Hemodynamic Instability; Vasoconstriction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Septic Shock

Adult patients with septic shock, admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively. Sedated and mechanically ventilated adult patients (\>18 years).

Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

Intervention Type: DRUG

1. 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.

Interventions

Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

1. 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Henrik Wolsted

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hvidovre Hospital

Hvidovre, Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Henrik Wolsted, MD

Role: CONTACT

Henrik.wolsted.01@regionh.dk

+45 21 49 44 85

Nicolai Bang Foss, MD, DMsC

Role: CONTACT

nicolai.bang.foss@regionh.dk

Facility Contacts

Henrik Wolsted

Role: primary

Hwolsted@gmail.com

21494485

Other Identifiers

HW-NA-Fluid-Measurements

Identifier Type: -

Identifier Source: org_study_id