Dexmedetomidine on Microcirculation in Septic Shock

Septic Shock Clinical Trial

Official title:

Dexmedetomidine Improve Microcirculatory Alterations in Initial Resuscitated Septic Shock Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270281
• Other study ID #: 2014ZDSYLL093.0
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: May 2017

Study information

• Verified date: December 2018
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. However, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

Description:

Septic shock is characterized by significant decline in vascular response and relative hypovolemia. Fluids and exogenous catecholamines are mainstay. However, even after initial resuscitation, microcirculatory dysfunctions still exist, and represent a direct physiologic link to organ failure and death. Therefore, therapeutic strategies aiming at improving microcirculation are performed.

Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. However, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

Based on the hypothesis that dexmedetomidine might improve microcirculation in initial resuscitated septic shock patients, the study was to investigate the effects of dexmedetomidine on microcirculation in early septic shock patients despite initial resuscitation. Meanwhile, to observe the possible mechanism of the effect, the correlation between dexmedetomidine dose and microcirculatory parameters as well as catecholamine level were performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Adult patients who met the following inclusion criteria were enrolled in the study: 1) With septic shock defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference for less than 24 hours.

2) After initial fluid resuscitation but still requiring norepinephrine to maintain arterial pressure or hyperlactacidemia.

3) Need ongoing analgesia and sedation. 4) Using advanced invasive hemodynamic monitoring techniques.

Exclusion criteria were as follows:

1. age less than 18 years.

2. pregnancy.

3. heart rate less than 55 beats per minute.

4. acute hepatic failure

5. brain injury.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Dexmedetomidine 0.7 Mcg/kg/h
CIF 0.7mcg/kg/h

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 (7)

Geloen A, Chapelier K, Cividjian A, Dantony E, Rabilloud M, May CN, Quintin L. Clonidine and dexmedetomidine increase the pressor response to norepinephrine in experimental sepsis: a pilot study. Crit Care Med. 2013 Dec;41(12):e431-8. doi: 10.1097/CCM.0b0 — View Citation

Hernández G, Tapia P, Alegría L, Soto D, Luengo C, Gomez J, Jarufe N, Achurra P, Rebolledo R, Bruhn A, Castro R, Kattan E, Ospina-Tascón G, Bakker J. Effects of dexmedetomidine and esmolol on systemic hemodynamics and exogenous lactate clearance in early — View Citation

Massey MJ, Hou PC, Filbin M, Wang H, Ngo L, Huang DT, Aird WC, Novack V, Trzeciak S, Yealy DM, Kellum JA, Angus DC, Shapiro NI; ProCESS investigators. Microcirculatory perfusion disturbances in septic shock: results from the ProCESS trial. Crit Care. 2018 — View Citation

Miranda ML, Balarini MM, Bouskela E. Dexmedetomidine attenuates the microcirculatory derangements evoked by experimental sepsis. Anesthesiology. 2015 Mar;122(3):619-30. doi: 10.1097/ALN.0000000000000491. — View Citation

Morelli A, Sanfilippo F, Arnemann P, Hessler M, Kampmeier TG, D'Egidio A, Orecchioni A, Santonocito C, Frati G, Greco E, Westphal M, Rehberg SW, Ertmer C. The Effect of Propofol and Dexmedetomidine Sedation on Norepinephrine Requirements in Septic Shock P — 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

Yeh YC, Wu CY, Cheng YJ, Liu CM, Hsiao JK, Chan WS, Wu ZG, Yu LC, Sun WZ. Effects of Dexmedetomidine on Intestinal Microcirculation and Intestinal Epithelial Barrier in Endotoxemic Rats. Anesthesiology. 2016 Aug;125(2):355-67. doi: 10.1097/ALN.00000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfused vascular density	Perfused vascular density was calculated by multiplying vessel density by the proportion of perfused vessels	One hour
Secondary	Microcirculatory flow index	Based on the major type of flow in all quadrants were determined with a semi-quantitative methodology	One hour
Secondary	Total vascular density	Vascular density was calculated by the number of vessels crossing these lines	One hour