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Anisodamine Critically Ill SeptIc Shock (ACIdoSIS)

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ClinicalTrials.gov Identifier: NCT02442440
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Zhongheng Zhang, Jinhua Central Hospital

Brief Summary:
Anisodamine has been widely used in China for its pharmacological effect on improving microcirculation during shock. It has been reported that anisodamine is effective in reducing mortality rate in children with meningitis. however, its effectiveness in patients with septic shock has not been systematically investigated. The aim of the study is to investigate the effectiveness of anisodamine in the treatment of patients with septic shock.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: anisodamine Phase 1 Phase 2

Detailed Description:

Septic shock is an important contributor of mortality in the intensive care unit (ICU). The crude mortality is reported to be from 30% to 65% (1-5). Although there are significant advances in the management of septic shock in recent decades, the mortality rate was only marginally reduced. For example, the CUB-Réa Network study reported that the mortality rate of septic shock declined from 62.1% in 1993 to 55.9% in 2000 (6). The well-known Surviving Sepsis Campaign has also made every effort to reduce mortality rate of severe sepsis and septic shock. The organization recommended bundled strategies including early goal directed therapy (EGDT) for the management of septic shock (7,8). Although EGDT was once the mainstay therapy of septic shock, its efficacy has been questioned by recent several large randomized controlled trials (9,10). Therefore, the treatment of septic shock is still a global challenge and there is no well-established intervention that can reduce its mortality.

Anisodamine is an active agent isolated from a Chinese herb medicine. Both experimental and clinical studies have shown some potential beneficial effects of anisodamine in improving outcomes of shock (11-13). It was reported that anisodamine could reduce the mortality rate of fulminant epidemic meningitis from 66.9% to 12.4% (14). The efficacy of anisodamine might be mediated via the inhibition of thromboxane synthesis, granulocyte and platelet aggregation (15). Although anisodamine has been widely used in the treatment of septic shock in mainland China, there is no solid evidence from well designed clinical trials to support its efficacy. The aim of the study is to investigate the effectiveness of anisodamine in the treatment of critically ill patients with septic shock.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Anisodamine for the Treatment of Critically Ill Patients With Septic Shock: a Randomized Controlled Trial
Study Start Date : April 2015
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: anisodamine group
administration of the drug
Drug: anisodamine
Anisodamine will be given first as bolus of 10 mg, followed by 0.1-0.5mg/kg/hr. The adjustment of pump infusion rate is largely at the discretion of treating physician, with the aim of improving microcirculation and limit the side effect to a minimum. For example, if serum lactate continues to elevate, the infusion rate can be increased. Discontinuation on severe side effect or recovery of shock (normalized lactate, weaned from vasopressor) or death.
Other Name: 654-2

No Intervention: control group
these arm do not use anisodamine, other resuscitation protocol is as usual.



Primary Outcome Measures :
  1. hospital mortality [ Time Frame: from ICU admission to hospital discharge (participants will be followed for the duration of hospital stay, an expected average of 28 days) ]
    the outcome will be assessed by using proportion of patients died, and relative risk will be reported.


Secondary Outcome Measures :
  1. lactate levels [ Time Frame: from ICU admission to hospital discharge (participants will be followed for the duration of hospital stay, an expected average of 28 days) ]
    the value was measured in mmol/l, and they will be compared between both arms.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with septic shock

Inclusion criteria included patients with sepsis plus use of vasopressors. Systemic inflammatory response syndrome (SIRS) is defined as meeting at least one of the following 3 criteria for a systemic inflammatory response. One of the SIRS criteria must be either the WBC criteria (a) or the body temperature criteria (b):

  1. White blood cell count >12,000 or <4,000 or >10% band forms
  2. Body temperature >38oC (any route) or <36oC (accepting core temperatures only; indwelling catheter, esophageal, rectal)
  3. Heart rate (> 90 beats/min) or receiving medications that slow heart rate or paced rhythm.

Suspected or documented infection included the following sites: thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and bacterial meningitis.

Septic shock was defined as sustained arterial hypotension with systolic blood pressure (SBP) < 90 mm Hg, mean arterial pressure (MAP) < 70 mm Hg, or an SBP decrease > 40 mm Hg, despite adequate fluid resuscitation. To ease clinical screening process, we defined septic shock as the requirement of vasopressors despite adequate fluid resuscitation. Vasopressors include norepinephrine, epinephrine, phenylephrine and dopamine>5mcg/kg/min.

Patients with following conditions will be excluded:

  1. Age<15 years old
  2. Moribund (expected to die within 24 hours)
  3. Stay in ICU for more than 24 hours
  4. Contraindications to anisodamine: elevated intracranial pressure, acute phase of intracranial hemorrhage, glaucoma, untreated bowel obstruction (surgically treated obstruction is not contraindicated), enlargement of prostate without urinary catheterization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442440


Contacts
Contact: zhongheng zhang, MMed 8657982553393 zh_zhang1984@hotmail.com

Locations
China, Guangdong
Huizhou first hospital Not yet recruiting
Huizhou, Guangdong, China, 516000
Contact: Xiaopeng Feng, MD       fengxiaopeng1977@163.com   
China, Hubei
Union Hospital, Tongji medical collegue, Huazhong university of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: You Shang, MD       shang_you@126.com   
Principal Investigator: You Shang, MD         
Sub-Investigator: Rui Wang, MD         
Sub-Investigator: Zhouxiong Xing, MD         
Sub-Investigator: Yuan Yu, MD         
Sub-Investigator: Shiying Yuan, MD         
Sub-Investigator: Xiaojing Zhou, MD         
Sub-Investigator: Hong Liu, MD         
Sub-Investigator: Yuanfa Tao         
Sub-Investigator: Huaqing Shu         
Sub-Investigator: Yaxing Wang         
Sub-Investigator: Yin Yuan         
Sub-Investigator: Jiancheng Zhang         
China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Xiangrong Zuo, MD       13913979197@139.com   
affiliated hospital, Jiangsu University Recruiting
Zhenjiang, Jiangsu, China
Contact: Dadong Liu, MD       583837931@qq.com   
China, Shandong
Binzhou People's hospital of Shandong province Recruiting
Binzhou, Shandong, China
Contact: Xin'an Wang, MD       wangxinan008@163.com   
Sub-Investigator: Rui Yin, MD         
China, Shanghai
department of critical care medicine, Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200001
Contact: Yuetian Yu, MD       fishyyt@hotmail.com   
China, Shanxi
Peace hospital of Changzhi medical college Recruiting
Changzhi, Shanxi, China
Contact: Zhenhua Zhu, MD       249263735@qq.com   
China, Zhejiang
Zhejiang Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Caibao Hu, MD       zjicu1996@163.com   
Sir Run Run Shaw hospital Recruiting
Hangzhou, Zhejiang, China, 321000
Contact: jiancang Zhou, MD       jiancangzhou@hotmail.com   
Sir Run Run Shaw hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Hong Yucai         
Jinhua Municipal Central Hospital Recruiting
Jinhua, Zhejiang, China, 321000
Contact: zhongheng zhang    8657982553393    zh_zhang1984@hotmail.com   
Contact: Xuqing Ji, MSc       xuqing_ji@163.com   
Principal Investigator: kun chen, MSc         
Sub-Investigator: Xiao Xu, MSc         
Sub-Investigator: Hongying Ni, MMed         
Principal Investigator: Zhongheng Zhang, MMed         
Sub-Investigator: Xuqing Ji, MSc         
Department of critical care medicine, The central hospital of Lishui City Recruiting
Lishui, Zhejiang, China, 323000
Contact: Xin Tian, MD       xqjytx@163.com   
Beilun People's hospital; The first affiliated hospital of Zhejiang university (Beilun Branch) Recruiting
Ningbo, Zhejiang, China
Contact: Zhiping Huang, MD       hnhzhp@sina.com   
Taizhou hospital of Zhejiang province Recruiting
Taizhou, Zhejiang, China, 317000
Contact: Chao Zhang, MD       zzcc200@163.com   
The first People's hospital of Yongkang Recruiting
Yongkang, Zhejiang, China
Contact: Bo Ren, MD       ykrenbo@163.com   
Sponsors and Collaborators
Jinhua Central Hospital
Investigators
Study Director: kun chen, MSc Jinhua Municipal Central Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhongheng Zhang, Dr., Jinhua Central Hospital
ClinicalTrials.gov Identifier: NCT02442440     History of Changes
Other Study ID Numbers: 2015-013
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Zhongheng Zhang, Jinhua Central Hospital:
anisodamine
septic shock

Additional relevant MeSH terms:
Shock
Shock, Septic
Critical Illness
Pathologic Processes
Disease Attributes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Anisodamine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Parasympatholytics
Autonomic Agents
Vasodilator Agents
Free Radical Scavengers