Effect of Different Strategies for Titrating a High MAP on Microcirculation

Phase 4

Completed

• Conditions: Hypertension; Septic Shock
• Interventions: Drug: Crystalloid; Drug: Norepinephrine

• Registration Number: NCT02085291
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study First Submitted: 2014-02-28
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Primary Completion: 2016-09
• Study Completion: 2017-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resp-FL	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. The target MAP was maintain MAP within 10% of the reference value.
Nonresp-NE	Norepinephrine	In Nonresp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.
Resp-NE	Norepinephrine	In Resp-NE group, norepinephrine was increased to enhance MAP within 10% of the reference value.

Primary Outcome Measures

Name	Time	Method
Perfused vessel density	20 minutes	Perfused vessel density of small vessels

Trial Locations

Locations (1)

Nanjing Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China