Effect of Different Strategies for Titrating a High MAP on Microcirculation

NCT02085291 | Completed Phase 4

• 2 other identifiers: 2014ZDll.2Targeting microcirculation
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the effect of fluids and norepinephrine for mean arterial pressure titration to patients' usual level on the microcirculation of initial resuscitated hypertensive septic shock patients.

Conditions

Septic Shock; Hypertension

Keywords

septic shock; microcirculation; norepinephrine

Outcome Measures

Primary Outcomes (1)

• Perfused vessel density

  Perfused vessel density of small vessels

  20 minutes

Study Arms (3)

Resp-FL

EXPERIMENTAL

Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one. The target MAP was maintain MAP within 10% of the reference value.

Drug: Crystalloid

Resp-NE

EXPERIMENTAL

In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.

Drug: Norepinephrine

Nonresp-NE

EXPERIMENTAL

In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

Norepinephrine infusion to titrate MAP to usual level

Also known as: NE group

Nonresp-NE; Resp-NE

Crystalloid DRUG

Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.

Also known as: Fluid group

Resp-FL

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive patients with septic shock for less than 24 hours. Septic shock was defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference.
• Initial fluid resuscitation was performed to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous hemoglobin saturation for more than 70%.
• Patients were still requiring NE to maintain the MAP of 65 mm Hg.

You may not qualify if:

• had severe untreated or uncontrolled hypertension (systolic blood pressure more than 180 mm Hg or/and diastolic blood pressure more than 110 mm Hg);
• were younger than 18 years old or pregnant;
• were unable to acquire the usual level or resting level of blood pressure;
• refused to participate the trial.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (5)

• Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836.

  PMID: 28903154 RESULT

• Elbers PW, Ince C. Mechanisms of critical illness--classifying microcirculatory flow abnormalities in distributive shock. Crit Care. 2006;10(4):221. doi: 10.1186/cc4969.

  PMID: 16879732 RESULT

• Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

  PMID: 28973220 RESULT

• 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 RESULT

• Pottecher J, Deruddre S, Teboul JL, Georger JF, Laplace C, Benhamou D, Vicaut E, Duranteau J. Both passive leg raising and intravascular volume expansion improve sublingual microcirculatory perfusion in severe sepsis and septic shock patients. Intensive Care Med. 2010 Nov;36(11):1867-74. doi: 10.1007/s00134-010-1966-6. Epub 2010 Aug 20.

  PMID: 20725823 RESULT

MeSH Terms

Conditions

Shock, Septic; Hypertension

Interventions

Norepinephrine; Crystalloid Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Haibo Qiu

  Southeastt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongda Hospital

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 12, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)