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Effect of Different Strategies for Titrating a High MAP on Microcirculation

Primary Purpose

Septic Shock, Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Norepinephrine
Crystalloid
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock; microcirculation; norepinephrine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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%.
  3. Patients were still requiring NE to maintain the MAP of 65 mm Hg.

Exclusion Criteria:

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

Sites / Locations

  • Nanjing Zhongda Hospital, Southeast University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Resp-FL

Resp-NE

Nonresp-NE

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Perfused vessel density
Perfused vessel density of small vessels

Secondary Outcome Measures

Full Information

First Posted
February 28, 2014
Last Updated
January 30, 2018
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02085291
Brief Title
Effect of Different Strategies for Titrating a High MAP on Microcirculation
Official Title
The Effect of Fluids and Norepinephrine for Mean Arterial Pressure Titration to Patients' Usual Levels on the Microcirculation of Initial Resuscitated Hypertensive Septic Shock Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Microcirculatory dysfunction plays an important role in the development of organ failure in patients with septic shock. Numerous studies focus on the effect of mean arterial pressure (MAP) titration on microcirculation, however, by what strategy is better for microcirculation in septic shock patients with previous hypertension is still a matter of debate. The goal of this study was to assess the effect of different strategies for MAP titration to individualized level on microcirculation in hypertensive septic shock patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Hypertension
Keywords
septic shock; microcirculation; norepinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resp-FL
Arm Type
Experimental
Arm Description
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.
Arm Title
Resp-NE
Arm Type
Experimental
Arm Description
In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
Arm Title
Nonresp-NE
Arm Type
Experimental
Arm Description
In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
NE group
Intervention Description
Norepinephrine infusion to titrate MAP to usual level
Intervention Type
Drug
Intervention Name(s)
Crystalloid
Other Intervention Name(s)
Fluid group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perfused vessel density
Description
Perfused vessel density of small vessels
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo Qiu
Organizational Affiliation
Southeastt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28903154
Citation
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.
Results Reference
result
PubMed Identifier
16879732
Citation
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.
Results Reference
result
PubMed Identifier
28973220
Citation
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.
Results Reference
result
PubMed Identifier
25887027
Citation
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.
Results Reference
result
PubMed Identifier
20725823
Citation
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.
Results Reference
result

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Effect of Different Strategies for Titrating a High MAP on Microcirculation

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