High MAP in Septic Shock With Hypertension

Septic Shock Clinical Trial

Official title:

High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443494
• Other study ID #: SoutheastUChina2011ZDllKY03.0
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2011
• Last updated: June 13, 2014
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

Description:

The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. Our goal was to assess the effect of MAP titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with septic shock for less than 24 hours

• Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70%

• Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP > 8mmHg and mean blood pressure > 65 mmHg

Exclusion Criteria:

• Pregnancy

• Age < 18 years

• Inability to acquire the usual level of MAP

• Refusal of consent by the patient or relative

• Participation in other trials during the last three months

• Hypertensive patients without hypertension treatment

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• NE
norepinephine

Locations

Country	Name	City	State
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

References & Publications (8)

Beloncle F, Lerolle N, Radermacher P, Asfar P. Target blood pressure in sepsis: between a rock and a hard place. Crit Care. 2013 Mar 26;17(2):126. doi: 10.1186/cc12543. — View Citation

Corrêa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495. — View Citation

Dubin A, Pozo MO, Casabella CA, Pálizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Pálizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17. — View Citation

Jhanji S, Stirling S, Patel N, Hinds CJ, Pearse RM. The effect of increasing doses of norepinephrine on tissue oxygenation and microvascular flow in patients with septic shock. Crit Care Med. 2009 Jun;37(6):1961-6. doi: 10.1097/CCM.0b013e3181a00a1c. — View Citation

LeDoux D, Astiz ME, Carpati CM, Rackow EC. Effects of perfusion pressure on tissue perfusion in septic shock. Crit Care Med. 2000 Aug;28(8):2729-32. — View Citation

Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. — View Citation

Sevransky JE, Nour S, Susla GM, Needham DM, Hollenberg S, Pronovost P. Hemodynamic goals in randomized clinical trials in patients with sepsis: a systematic review of the literature. Crit Care. 2007;11(3):R67. Review. — View Citation

Thooft A, Favory R, Salgado DR, Taccone FS, Donadello K, De Backer D, Creteur J, Vincent JL. Effects of changes in arterial pressure on organ perfusion during septic shock. Crit Care. 2011;15(5):R222. doi: 10.1186/cc10462. Epub 2011 Sep 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Pressure	As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.; After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.	Target MAP stabilization for 30 min	Yes
Secondary	Perfused Vessel Density	Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by SDF, including the parameters of perfused vessel density	Target MAP stabilization for 30 min	Yes