Evidence map›Paper›PMID 37518088›Full record

ArticleBMJ open2023

Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial.

Linhui Hu, Xinjuan Zhou, Jinbo Huang, Yuemei He, Quanzhong Wu, Xiangwei Huang, Kunyong Wu, Guangwen Wang, Sinian Li, Xiangyin Chen and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Linhui HuDepartment of Critical Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.ORCID 0000-0002-1649-6624
Xinjuan ZhouClinical Research Center, Center of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
Jinbo HuangClinical Research Center, Center of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
Yuemei HeClinical Research Center, Center of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
Quanzhong WuDepartment of Surgery Intensive Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.
Xiangwei HuangDepartment of Critical Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.
Kunyong WuCenter of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
Guangwen WangCenter of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
Sinian LiDepartment of Neurocritical Care Unit, Maoming People's Hospital, Maoming, Guangdong, China.
Xiangyin ChenDepartment of Surgery Intensive Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.
Chunbo ChenDepartment of Critical Care Medicine, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, 518020, China gghccm@163.com.ORCID 0000-0001-5662-497X
Jinan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSepsis is a life-threatening immune disorder resulting from an dysregulated host response to infection. Adjuvant therapy is a valuable complement to sepsis treatment. Lipoic acid has shown potential in attenuating sepsis-induced immune dysfunction and organ injury in vivo and in vitro studies. However, clinical evidence of lipoic acid injection in sepsis treatment is lacking. Hence, we devised a randomised controlled trial to evaluate the efficacy and safety of lipoic acid injection in improving the prognosis of sepsis or septic shock patients. METHODS AND ANALYSIS: A total of 352 sepsis patients are planned to be recruited from intensive care units (ICUs) at eight tertiary hospitals in China for this trial. Eligible participants will undergo randomisation in a 1:1 ratio, allocating them to either the control group or the experimental group. Both groups received routine care, with the experimental group also receiving lipoic acid injection and the control group receiving placebo. The primary efficacy endpoint is 28-day all-cause mortality. The secondary efficacy endpoints are as follows: ICU and hospital mortality, ICU and hospital stay, new acute kidney injury in ICU, demand and duration of life support, Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation II (APACHE II) and changes from baseline (ΔSOFA/ΔApache II), arterial blood lactate (LAC) and changes from baseline (ΔLAC), blood procalcitonin, high-sensitivity C-reactive protein, interleukin-2 (IL-2), IL-4, IL-6, IL-10, tumour necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) and changes from baseline on day 1 (D1), D3, D5 and D7. Clinical safety will be assessed through analysis of adverse events. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Maoming People's Hospital (approval no. PJ2020MI-019-01). Informed consent will be obtained from the participants or representatives. The findings will be disseminated through academic conferences or journal publications.

trial registrationChiCTR2000039023.

Indexed as

SepsisThioctic AcidHumansIntensive Care UnitsPrognosisRandomized Controlled Trials as TopicSingle-Blind MethodThioctic AcidAdult intensive & critical careClinical trialsProtocols & guidelinesRandomized Controlled Trial

Identifiers

PMID37518088
PMCPMC10387639
OpenAlexW4385406940

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.