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Effect of Different Strategies for Titrating a High MAP on Microcirculation

Sponsor
Southeast University, China (Other)
Overall Status
Completed
CT.gov ID
NCT02085291
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
42.1
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Resp-FL

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
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.
Other Names:
  • Fluid group

    		•
    Experimental: Resp-NE

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

    Drug: Norepinephrine
    Norepinephrine infusion to titrate MAP to usual level
    Other Names:
  • NE group

    		•
    Experimental: Nonresp-NE

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

    Drug: Norepinephrine
    Norepinephrine infusion to titrate MAP to usual level
    Other Names:
  • NE group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Perfused vessel density [20 minutes]

      Perfused vessel density of small vessels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Zhongda Hospital, Southeast University Nanjing Jiangsu China 210000

    Sponsors and Collaborators

    • Southeast University, China

    Investigators

    • Principal Investigator: Haibo Qiu, Southeastt University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jingyuan,Xu, Zhongda Hospital, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT02085291
    Other Study ID Numbers:
    • 2014ZDll.2
    • Targeting microcirculation
    First Posted:
    Mar 12, 2014
    Last Update Posted:
    Jan 31, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jingyuan,Xu, Zhongda Hospital, Southeast University, China
    septic shock; microcirculation; norepinephrine
    Additional relevant MeSH terms:
    Shock, Septic
    Shock
    Norepinephrine

    Study Results

    No Results Posted as of Jan 31, 2018