The Effects of Dexmedetomidine on Microcirculation and Surgical Outcomes After Cardiac Surgeries

NCT02786212 | Completed

• 1 other identifier: 201512224MINB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery with cardiopulmonary bypass (CPB) provokes a systemic inflammatory response that can often lead to dysfunction of major organs. Activation of the contact system, endotoxemia, surgical trauma, and ischemic reperfusion injury are all possible triggers of inflammation. Previous studies demonstrated that pro-inflammatory cytokines play an important role during this process. However, very little is known about the susceptibility of the splanchnic organs to ischemic reperfusion injury. Although the incidence of intestinal complications reported to be low, the in-hospital mortality in these patients was high at 15% to 63%. Dexmedetomidine, a highly selective α2-adrenergic agonist, can reduce the consumption of other sedative and antinociceptive drugs and provide sufficient sedative effects with minimal respiratory side effects. In addition, dexmedetomidine gradually has gained popularity in the field of critical care. Preemptive administration of dexmedetomidine has shown to be protective against inflammation, intestinal, renal, and myocardial injuries in animal and human studies. Dexmedetomidine is also used as an anesthetic adjuvant during surgery to offer good perioperative hemodynamic stability and an intraoperative anesthetic-sparing effect. Perioperative use of dexmedetomidine can reduce intestinal and hepatic injury after hepatectomy with inflow occlusion under general anesthesia. However, whether or not it can exert protective effects on the above-mentioned organs, especially intestine, after cardiac surgery remains unclear. The aim of this study is to evaluate the effects of dexmedetomidine on intestinal, hepatic, and other organ injury in patients receiving cardiac surgery with CPB. In this double-blinded randomized controlled study, serum diamine oxidase activity, which is a sensitive and specific marker for the detection of intestinal injury, is taken as the primary endpoint. Other parameters reflecting the functions of liver (AST/ALT), lung (lung injury score and CC-16), kidney (BUN/Cre), and heart (CK-MB/Troponin T), the biomarker of endothelial injury (endocan) will also be determined. Besides, microcirculation parameters measured with Cytocam® and near-infrared spectroscopy (NIRS) will be used to estimate the protective effect of dexmedetomidine on microcirculation. The variables will be collected perioperatively and will be followed up for 3 days after the surgery. Clinical outcome parameters will be followed up for 3 months after the surgery.

Conditions

Cardiac Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• Perioperative changes in perfused vessel density (PVD)

  PVD measured by using sublingual vital videomicroscopy

  1 hours, 24 hours, and 48 hours after surgery

Secondary Outcomes (1)

• Incidence of postoperative acute kidney injury

  48 hours after surgery

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

Patients receiving intraoperative dexmedetomidine infusion. Infusion duration: from 10 minutes after anesthetic induction to the end of surgery.

Drug: Dexmedetomidine

control

PLACEBO COMPARATOR

control group, receiving same volume of normal saline infusion.

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

dexmedetomidine

Normal Saline DRUG

control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-emergent cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• left ventricle ejection fraction \< 40%
• acute myocardial infarction within 3 months
• angina within 48 hours before surgery
• COPD
• previous history of inflammatory bowel disease
• diarrhea within 7 days before surgery
• previous cardiac surgery
• receiving non-pharmacological cardiac supportive management
• previous pulmonary embolism
• previous deep vein thrombosis
• allergic to dexmedetomidine
• refractory bradycardia (HR \< 60/min )

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Po-Yuan Shih, MD

  Department of Anesthesiology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 30, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 6, 2024

Record last verified: 2020-04

Locations

TW (1)