https://orcid.org/0000-0002-7694-1507
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Abstract
Objective
This study aimed to evaluate the effectiveness of therapeutic lumbar drainage (LD) compared to therapeutic lumbar puncture (LP) for the management of intracranial hypertension (ICH) among HIV-positive patients with cryptococcal meningitis (CM).
Methods
The study was a multicenter prospective non-randomized interventional clinical trial. One hundred and sixteen HIV-associated CM patients were identified who presented with ICH (≥250 mmH2O). The LP group comprised 76 cases, while the LD group consisted of 40 cases. We compared mortality, intracranial pressure (ICP) normalization rate, and clinical symptom remission at 10 weeks, between the two groups.
Results
The cumulative mortality at week 10 was 22.4% in the LP group and 20% in the LD group (p = .927), without any significant difference in mortality between the two groups. Improvement after treatment at 2-weeks, ICP normalization, and headache reversal event occurrence in the two groups showed no significant difference (p > .05). The incidence of CSF Cryptococcus clearance at two weeks in the LD group was significantly higher than in the LP group (p < .05). The frequency of invasive lumbar therapeutic procedures in the LP group during the first week was higher than that of the LD group (p < .05). Localized infection at the puncture site occurred more frequently in the LD group than in the LP group (p < .05).
Conclusion
For HIV-positive CM patients with an elevated ICP, LD and LP are comparably effective and safe options to normalize ICP. LP increases the frequency of invasive lumbar therapeutic procedures but does not incur more risk of infection events at the puncture site, while LD may accelerate CSF Cryptococcus clearance but may induce more frequent localized infection.
Trial registration
This study was registered as one of 12 trials under a general project at the Chinese Clinical Trial Registry (ChiCTR1900021195).
Transparency
Declaration of funding
This work was supported by the National Science and Technology Major Project of China During the 13th Five-year Plan Period (2018ZX10302104), Chongqing Medical Scientific Research project from Joint Project of Chongqing Health Commission and Science and Technology Bureau (2020GDRC004), Chongqing Science and Technology Commission (cstc2020jscx-cylh0001), and Chongqing Talent Cultivation Program (cstc2021ycjh-bgzxm0275).
Declaration of financial/other relationships
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
Yao-kai Chen and Yan-qiu Lu: study design. Xue-jiao He, Yu-shan Wu, Wei Zhang, Jian-hua Yu, Tong-tong Yang, Li-jun Xu, Ke Lan, and De-fa Zhang: data acquisition. Xiao-lei Xu, Ting Zhao, and Yan-qun Huang: statistical analyses. Xiao-lei Xu: drafting of the manuscript. The manuscript was reviewed, revised, copy-edited, and proofread by Vijay Harypursat and Yao-kai Chen.
Acknowledgements
The authors wish to express our gratitude to the institutions that played critical roles in the data collection process. We also would like to acknowledge the staff at each participating site who have assisted in obtaining ethics and operational approval for the study.
Ethical approval
This study was approved by the Ethics Committee of Chongqing Public Health Medical Center (registry number 2019-003-02-KY). All clinical investigations were conducted according to the principles expressed in the Declaration of Helsinki.