Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02519699
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Flavia Ribeiro Machado, Federal University of São Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: norepinephrine Phase 4

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension
Study Start Date : March 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Norepinephrine
Noradrenaline continuous infusion IV
Drug: norepinephrine
Increase in mean arterial pressure using norepinephrine
Other Name: noradrenaline




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519699


Locations
Layout table for location information
Brazil
Hospital São Paulo - Universidade Federal de São Paulo
São Paulo, Brazil, 04024-003
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Layout table for investigator information
Study Chair: Flavia Machado, PhD Federal University of São Paulo

Publications:
Layout table for additonal information
Responsible Party: Flavia Ribeiro Machado, Professor and Chair of Intensive Care Anesthesiology, Pain and Intensive Care Department, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02519699     History of Changes
Other Study ID Numbers: CEP173.166
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Shock
Shock, Septic
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents