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AnteayerBMJ Open

Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol

Por: Wang · Z. · Li · T. · Zhang · Z. · Yuan · M. · Shi · M. · Wang · F.-S. · Linghu · E.-Q. · Shi · L.
Introduction

There are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.

Methods and analysis

This study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0x107, 1.0x108, 1.5x108 or 2.0x108 cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.

Ethics and dissemination

The study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.

Trial registration number

NCT05227846.

Innovative Telerehabilitation Enhanced Care Programme (ITECP) in young and middle-aged patients with haemorrhagic stroke to improve exercise adherence: protocol of a multicentre randomised controlled trial

Por: Zhang · Y. · Jin · Q. · Ji · C. · Yuan · P. · Chen · L.
Introduction

Exercise rehabilitation is crucial for promoting the rehabilitation of limb motor function in people who had stroke and is related to a better prognosis. However, the exercise adherence of patients is low, which affects the effect of exercise rehabilitation. This study aims to evaluate the effects of the Innovative Telerehabilitation Enhanced Care Programme (ITECP) on exercise adherence in young and middle-aged patients with haemorrhagic stroke. We hypothesise that patients trained with ITECP will show greater improvement in exercise adherence and muscle strength than patients with routine exercise rehabilitation.

Methods and analysis

This is a randomised controlled, evaluator-blinded multicentre superiority trial to be implemented at four tertiary grade-A hospitals in eastern, western, northern and central China. Patients in the experimental group will receive ITECP while those in the control group will receive routine exercise rehabilitation. Both groups will receive routine care. The primary outcome measure is exercise adherence, while secondary outcome measures include muscle strength, activities of daily living, exercise self-efficacy, quality of life, rate of exercise-related adverse events and readmission. These will be measured at baseline, predischarge as well as 1 and 3 months postdischarge.

Ethics and dissemination

The study has obtained ethical approval from the Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School (2021-381-02). The results will be shared with young and middle-aged patients with haemorrhagic stroke, policy-makers, the general public, as well as academia.

Trial registration number

Chinese Clinical Trials Registry (ChiCTR 2200066498).

Effect of percutaneous cerebral oximetry-guided anaesthetic management on postoperative delirium in older adults undergoing off-pump coronary artery bypass grafting: study protocol for a single-centre prospective randomised controlled trial in a tertiary

Por: Tian · L. · Wang · H. · Jia · Y. · Jin · L. · Zhou · C. · Zhou · H. · Yuan · S.
Introduction

Postoperative delirium is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity and mortality. Many studies have shown that cerebral desaturation is associated with increased risk of postoperative delirium during on-pump cardiac surgery. However, few studies have focused on the effect of optimising regional cerebral oxygen saturation (rSO2) on postoperative delirium during off-pump CABG. The purpose of this study is to investigate whether intraoperative anaesthetic management based on percutaneous cerebral oximetry monitoring decreases the incidence of postoperative delirium in older adults undergoing off-pump CABG.

Methods

This single-centre randomised controlled trial will randomly assign 200 patients to the intervention group or the control group at a ratio of 1:1. The patients in the intervention group will be observed by percutaneous cerebral oximetry monitoring that the desaturation (a drop of more than 20% from baseline value or rSO2 less than 55% for >60 consecutive seconds at either probe) during the procedure triggered the intervention strategies, while the cerebral oximetry data of the control group will be hidden from the clinical team and patients will be anaesthetised by the usual anaesthetic management. The primary outcome will be the incidence of postoperative delirium during the first 7 days after off-pump CABG. Delirium will be comprehensively evaluated by the combination of the Richmond Agitation Sedation Scale and the Confusion Assessment Method for the intensive care unit. The secondary outcomes will include the incidence of postoperative acute kidney injury and myocardial infarction during the hospital stay, as well as the intensive care unit and hospital length of stay.

Ethics and dissemination

This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2022–1824). Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.

Trial registration number

ChiCTR2300068537.

Willingness to vaccinate against herpes zoster in Chinese urban population: a mixed-methods study

Por: Wang · M. · Hu · M. · Wang · Y. · Long · C. · Xia · Y. · Zhu · D. · Zhao · W. · Yuan · B. · He · P.
Objective

Although the herpes zoster vaccine has been available in mainland China since June 2020, residents’ knowledge of herpes zoster and the herpes zoster vaccine is poor, and vaccination rates are low, especially among the elderly, who are at high risk for herpes zoster. This study assessed willingness to be vaccinated against herpes zoster and factors associated with vaccination among urban residents in China.

Methods

A mixed-methods study was conducted in community health centres from August 2022 to September 2022. We used convenience sampling to select 2864 residents from 9 Chinese cities for the quantitative study and 67 adults for the qualitative study. A structured questionnaire was used for the quantitative study, and data were collected through face-to-face interviews. Multinomial logistic regression was used to analyse factors associated with willingness to vaccinate. Qualitative data were analysed using thematic analysis of barriers to herpes zoster vaccination.

Results

A total of 2864 eligible respondents were included in the study. Of these, 42.67% intended to receive the herpes zoster vaccine, 21.44% refused and 35.89% were hesitant. The results of the quantitative and qualitative analyses showed that the factors associated with respondents’ willingness to be vaccinated against herpes zoster included: personal characteristics such as gender, age and income; knowledge and attitudes about herpes zoster and the vaccine; vaccine characteristics such as efficacy, safety and price; and other factors such as pain tolerance and accessibility to vaccination.

Conclusion

The low willingness to vaccinate, especially among the elderly, is mainly related to their poor knowledge and negative attitude towards the infection and vaccination. Therefore, health education about herpes zoster, immunisation promotion, and improvement of accessibility and affordability would be valuable in China.

Association of serum potassium level with dietary potassium intake in Chinese older adults: a multicentre, cross-sectional survey

Por: Yuan · Y. · Jin · A. · Zhao · M.-H. · Wang · H. · Feng · X. · Qiao · Q. · Zhang · R. · Gao · R. · Wu · Y.
Objectives

Evidence linking dietary potassium and serum potassium is virtually scarce and inconclusive. The aim of the study was to investigate the association between serum potassium level and potassium intake measured by 24-hour urine. We also explored whether the association differed across health conditions.

Design

A cross-sectional study conducted from September 2017 to March 2018.

Setting

48 residential elderly care facilities in northern China.

Participants

Participants aged 55 years and older and with both serum potassium and 24-hour urinary potassium measured were classified as having a low (apparently healthy), moderate (with ≥1 health condition but normal renal function) and high (with ≥1 health condition and abnormal renal function) risk of hyperkalaemia.

Exposure

Potassium intake is measured by 24-hour urinary potassium.

Outcomes

Serum potassium in association with potassium intake after adjustment for age, sex, region and accounting for the cluster effect.

Results

Of 962 eligible participants (mean age 69.1 years, 86.8% men), 17.3% were at low risk, 48.4% at moderate risk and 34.3% at high risk of hyperkalaemia. Serum potassium was weakly associated with 24-hour urinary potassium among individuals with moderate (adjusted β=0.0040/L; p=0.017) and high (adjusted β=0.0078/L; p=0.003) but not low (adjusted β=0.0018/L; p=0.311) risk of hyperkalaemia.

Conclusions

A weak association between dietary potassium intake and serum potassium level existed only among individuals with impaired renal function or other health conditions but not among apparently healthy individuals. The results imply that increasing dietary potassium intake may slightly increase the risk of hyperkalaemia but may also decrease the risk of hypokalaemia in unhealthy individuals, both of which have important health concerns.

Trial registration number

NCT03290716; Post-results.

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