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Completed

NCT Number: NCT02519699

Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

The optimal levels of mean arterial pressure that must be achieved in septic shock are subject of debate. Studies tried to correlate blood pressure increase in patients with septic shock with microcirculation. However, there are few studies that specifically assessed septic shock patients with previous arterial hypertension. The main objective of this study is to evaluate the effect of increased blood pressure level in the microcirculation of these patients and compare them with patients without arterial hypertension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital São Paulo - Universidade Federal de São Paulo

São Paulo, 04024-003, Brazil

About this study

Hypothesis: After a rise in mean arterial pressure, microcirculation improvement will occur only in the previously hypertensive patients.

Study design: Prospective clinical trial Setting: Intensive care units of the Anesthesiology Department at the Federal University of Sao Paulo and the intensive care unit of Kidney Hospital.

Studied population: Forty patients will be included, being 20 without known history of systemic arterial hypertension and 20 with this diagnosis for at least 2 years and already with clinical or subclinical organ damage.

Inclusion criteria

age over than 18 years old, norepinephrine drug use for at least 12 hours and for less than 72 hours, sedation level equal or deeper than Ramsay 4, blood pressure stable for the last 30 minutes prior to inclusion, central venous catheter in place and signed informed consent.

Exclusion criteria

pregnancy, cirrhosis, systemic sclerosis, and need to maintain mean arterial pressure above 65mmHg for others conditions.

Intervention: noradrenaline dose will be risen to obtain a mean arterial pressure of 85-90 mmHg.

Assessments and outcome: Systemic hemodynamic (central venous oxygen saturation, cardiac output, heart rate, central venous pressure) and sublingual microcirculation variables (microcirculatory flow index, total vascular density, proportion of perfused vessels, perfused vascular density) will be measured before and after the rise in mean arterial pressure. Sidestream darkfield will be used to assess microcirculation. The variation between those variables before and after the intervention will be compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age over than 18 years old,
  • norepinephrine drug use for at least 12 hours and for less than 72 hours,
  • sedation level equal or deeper than Ramsay 4,
  • blood pressure stable for the last 30 minutes prior to inclusion,
  • central venous catheter in place and
  • signed informed consent.

Exclusion criteria

  • pregnancy,
  • cirrhosis,
  • systemic sclerosis, and
  • need to maintain mean arterial pressure above 65mmHg for others conditions

Treatment and study plan

norepinephrine

Drug

Increase in mean arterial pressure using norepinephrine

Other names: noradrenaline

Primary outcomes

  1. Microcirculatory flow index (MIF) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

    Time frame: after 20 min

    MIF will be measured in points varying from 0 to 4

Secondary outcomes

  1. Total vascular density (TVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

    Time frame: after 20 min

    TVD will be measured in mm/mm2

  2. Perfused vascular density (PVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

    Time frame: after 20 min

    PVD will be measured in mm/mm2

  3. Proportional perfused vessels (PPV) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine

    Time frame: after 20 min

    PPV will be measured in percentage

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Aug 11, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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