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Septic ShockPhase 1/2ACIdoSISNCT02442440

Anisodamine Critically Ill SeptIc Shock

A Phase 1/2 study testing anisodamine in people with Septic Shock, run by Jinhua Central Hospital at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Septic Shock
What is being tested?
anisodamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
355 participants
Where
15 sitesChina
Study dates
Apr 2015to 1 Oct 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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):
  • White blood cell count >12,000 or <4,000 or >10% band forms
  • Body temperature >38oC (any route) or <36oC (accepting core temperatures only; indwelling catheter, esophageal, rectal)
  • 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.
Show all 12Show fewer
  • 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:
  • Age<15 years old
  • Moribund (expected to die within 24 hours)
  • Stay in ICU for more than 24 hours
  • 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.

Who cannot join

None listed.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Binzhou People's hospital of Shandong province

    Binzhou, Shandong

  • Peace hospital of Changzhi medical college

    Changzhi, Shanxi

  • The first People's hospital of Yongkang

    Guli, Zhejiang

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310000

  • Sir Run Run Shaw hospital

    Hangzhou, Zhejiang, 321000

  • Sir Run Run Shaw hospital

    Hangzhou, Zhejiang

  • Huizhou first hospital

    Huizhou, Guangdong, 516000

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

  • Department of critical care medicine, The central hospital of Lishui City

    Lishui, Zhejiang, 323000

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Beilun People's hospital; The first affiliated hospital of Zhejiang university (Beilun Branch)

    Ningbo, Zhejiang

  • department of critical care medicine, Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200001

  • Taizhou hospital of Zhejiang province

    Taizhou, Zhejiang, 317000

  • Union Hospital, Tongji medical collegue, Huazhong university of Science and Technology

    Wuhan, Hubei

  • affiliated hospital, Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: Effectiveness of Anisodamine for the Treatment of Critically Ill Patients With Septic Shock: a Randomized Controlled Trial

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.

Read the 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.

Conditions
Septic Shock
Being tested
anisodamine
Keywords
anisodamine, septic shock
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anisodamineDrug

    Also called 654-2

    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.

Study groups in NCT02442440
Study groupRoleWhat they receive
anisodamine groupExperimentaladministration of the drug
Receives: Drug: anisodamine
control groupNo interventionthese arm do not use anisodamine, other resuscitation protocol is as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hospital mortality

    the outcome will be assessed by using proportion of patients died, and relative risk will be reported.

    Measured: from ICU admission to hospital discharge (participants will be followed for the duration of hospital stay, an expected average of 28 days)

Secondary outcomes (1)

  1. lactate levels

    the value was measured in mmol/l, and they will be compared between both arms.

    Measured: from ICU admission to hospital discharge (participants will be followed for the duration of hospital stay, an expected average of 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02442440
Sponsor's protocol ID
2015-013
Acronym
ACIdoSIS
Status last verified
Sep 2021
First submitted
30 Apr 2015
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Yu Y, Zhu C, Hong Y, Chen L, Huang Z, Zhou J, Tian X, Liu D, Ren B, Zhang C, Hu C, Wang X, Yin R, Gao Y, Zhang Z. Effectiveness of anisodamine for the treatment of critically ill patients with septic shock: a multicentre randomized controlled trial. Crit Care. 2021 Sep 27;25(1):349. doi: 10.1186/s13054-021-03774-4.

    PubMed 34579741

  • Zheng Y, Li Y, Liu X, Zhang R, Wang Z, Sun H, Liu S. A phase III, multicenter randomized controlled trial of neo-adjuvant chemotherapy paclitaxel plus cisplatin versus surgery alone for stage IIA-IIIB esophageal squamous cell carcinoma. J Thorac Dis. 2017 Jan;9(1):200-204. doi: 10.21037/jtd.2017.01.44.

    PubMed 28203424

  • Zhang Z, Zhou J, Shang Y, Wang X, Yin R, Zhu Z, Chen W, Tian X, Yu Y, Zuo X, Chen K, Ji X, Ni H; Anisodamine Critically Ill SeptIc Shock (ACIdoSIS) study group. Effectiveness of anisodamine for the treatment of critically ill patients with septic shock (ACIdoSIS study): study protocol for randomized controlled trial. Ann Transl Med. 2015 Oct;3(17):246. doi: 10.3978/j.issn.2305-5839.2015.10.03.

    PubMed 26605292

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing anisodamine in people with Septic Shock, run by Jinhua Central Hospital at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02442440, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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Anisodamine Critically Ill SeptIc Shock (NCT02442440) | AzTrials