Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

NCT02519699 | Completed Phase 4

• 1 other identifier: CEP173.166
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

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

  MIF will be measured in points varying from 0 to 4

  after 20 min

Secondary Outcomes (3)

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

  after 20 min

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

  after 20 min

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

  after 20 min

Study Arms (1)

Norepinephrine

EXPERIMENTAL

Noradrenaline continuous infusion IV

Drug: norepinephrine

Interventions

norepinephrine DRUG

Increase in mean arterial pressure using norepinephrine

Also known as: noradrenaline

Norepinephrine

Eligibility Criteria

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

You may qualify if:

• 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,
• central venous catheter in place and
• signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital São Paulo - Universidade Federal de São Paulo

São Paulo, São Paulo, 04024-003, Brazil

Location

Related Publications (5)

• Xu JY, Ma SQ, Pan C, He HL, Cai SX, Hu SL, Liu AR, Liu L, Huang YZ, Guo FM, Yang Y, Qiu HB. A high mean arterial pressure target is associated with improved microcirculation in septic shock patients with previous hypertension: a prospective open label study. Crit Care. 2015 Mar 30;19(1):130. doi: 10.1186/s13054-015-0866-0.

  PMID: 25887027 BACKGROUND

• Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.

  PMID: 19534818 BACKGROUND

• Correa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495.

  PMID: 23363690 BACKGROUND

• Leone M, Asfar P, Radermacher P, Vincent JL, Martin C. Optimizing mean arterial pressure in septic shock: a critical reappraisal of the literature. Crit Care. 2015 Mar 10;19(1):101. doi: 10.1186/s13054-015-0794-z.

  PMID: 25888071 BACKGROUND

• Fiorese Coimbra KT, de Freitas FGR, Bafi AT, Pinheiro TT, Nunes NF, de Azevedo LCP, Machado FR. Effect of Increasing Blood Pressure With Noradrenaline on the Microcirculation of Patients With Septic Shock and Previous Arterial Hypertension. Crit Care Med. 2019 Aug;47(8):1033-1040. doi: 10.1097/CCM.0000000000003795.

  PMID: 31094744 DERIVED

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

Study Officials

• Flavia Machado, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Intensive Care Anesthesiology, Pain and Intensive Care Department

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 11, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

BR (1)