Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

NCT05225402 | Recruiting DMC FDA Drug

• 1 other identifier: HW-NA-Fluid-Measurements
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Septic Shock; Norepinephrine; Hemodynamic; Microcirculation; Intensive Care

Outcome Measures

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.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.

  Through study completion, an average of 1 year

• Microcirculation/perfusion measures during intervention.

  Through study completion, an average of 1 year

• CO measurement method

  Through study completion, an average of 1 year

Study Arms (1)

Septic Shock

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

Drug: Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

Interventions

Hemodynamic measurements during reduction in Norepinephrine and fluid boli. 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.

Septic Shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

45 adult patients with septic shock according to inclusion criteria admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, Copenhagen, 2665, Denmark

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Henrik Wolsted, MD

CONTACT

+45 21 49 44 85; Henrik.wolsted.01@regionh.dk

Nicolai Bang Foss, MD, DMsC

CONTACT

nicolai.bang.foss@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 4, 2022
• Study Start: March 8, 2022
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)