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NCT Number: NCT02085291

Effect of Different Strategies for Titrating a High MAP on Microcirculation

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

norepinephrine

Drug

Norepinephrine infusion to titrate MAP to usual level

Other names: NE group

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.

Other names: Fluid group

Primary outcomes

  1. Perfused vessel density

    Time frame: 20 minutes

    Perfused vessel density of small vessels

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 12, 2014
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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