Evidence map›Paper›PMID 41477182›Full record

Trial reportDrug design, development and therapy2025

The Effect of Methylene Blue on Sublingual Microcirculation in Patients with Septic Shock: A Randomized Controlled Trial.

Cuicui Dong, Jiaqi Zhu, Hang Ni, Yanfang Chen, Benjia Chen, Mengqin Zhang, Ke Cui, Sheng Zhang, Yongpo Jiang, Yinghe Xu

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2025. 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
–field-weighted citation impact
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. 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

10 authors.

Cuicui Dong *Department of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Jiaqi Zhu *Department of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Hang Ni *Department of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Yanfang ChenDepartment of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Benjia ChenDepartment of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Mengqin ZhangDepartment of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Ke CuiDepartment of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Sheng ZhangDepartment of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Yongpo JiangDepartment of Intelligent Medical Imaging, Sensing and Non-Invasive Rapid Testing, Zhejiang Engineering Research Center, Taizhou, Zhejiang, People's Republic of China.ORCID 0000-0002-5681-3663
Yinghe XuDepartment of Critical Care Medicine, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Methylene blue (MB) has been proposed as an adjunctive therapy in the early management of septic shock; however, its effects on microcirculatory function remain poorly understood. This study aimed to investigate whether MB infusion improves sublingual microcirculatory parameters in patients with septic shock. Methods: In this single-center, randomized controlled trial, participants were allocated in a 1:1 ratio to either the MB group or the control group. The MB group received an intravenous bolus of 2 mg/kg MB over 15 minutes, followed by a continuous infusion of 1 mg/kg MB diluted in 500 mL of 0.9% saline via a central venous catheter for 12 hours. The control group received an equivalent volume of saline. The primary endpoint was the change in sublingual microcirculation parameters from baseline to 24 hours, assessed using a repeated-measures mixed-effects model. Secondary endpoints included 28-day organ support-free days and 28-day mortality. Results: Among the 72 randomized participants, 70.8% (n=51) were male, with a mean age of 68.6±13.5 years. Following MB treatment, the mean microvascular flow index (MFI) in the MB group was 2.78, compared to 2.51 in the control group. MMRM analysis demonstrated that MB significantly improved MFI (least squares mean difference [95% CI]: 0.21 [0.09, 0.33], P=0.001), with significant increases observed as early as 1 hour post-intervention (T1: 0.24 [0.06, 0.42], P=0.009), and this effect persisted up to 24 hours (T24: P=0.005). However, no significant differences were observed between the groups in 28-day mortality (25.0% [9/36] vs 41.7% [15/36], P=0.200) or organ support-free days (20.0 [1.0-22.0] vs 16.0 [1.3-22.0], P=0.910). Conclusions: Although MB improved sublingual microcirculatory parameters, these improvements did not translate into benefits in organ function or survival outcomes. Trial Registration: chictr.org.cn ChiCTR 2400081549.

Indexed as

Methylene BlueMicrocirculationMouth FloorShock, SepticAgedFemaleHumansMaleMiddle AgedMethylene Bluemethylene blueorgan dysfunctionprognosisseptic shocksublingual microcirculationvasoactive agents

Identifiers

PMID41477182
PMCPMC12751372

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Registered trials

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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.