Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

NCT ID: NCT02519699

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-01-31

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.

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.

Conditions

Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Norepinephrine

Noradrenaline continuous infusion IV

Group Type: EXPERIMENTAL

norepinephrine

Intervention Type: DRUG

Increase in mean arterial pressure using norepinephrine

Interventions

norepinephrine

Increase in mean arterial pressure using norepinephrine

Intervention Type: DRUG

Other Intervention Names

noradrenaline

Eligibility 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

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

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Flavia Ribeiro Machado

Professor and Chair of Intensive Care Anesthesiology, Pain and Intensive Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia Machado, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Hospital São Paulo - Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 25887027 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19534818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23363690 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25888071 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31094744 (View on PubMed)

Other Identifiers

CEP173.166

Identifier Type: -

Identifier Source: org_study_id