Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial

BackgroundProgressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.ObjectiveTo assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.ParticipantsThe RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.InterventionIntraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.Primary outcomeCognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.ResultsOf the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).ConclusionDRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.Trial registration numberISRCTN80286058.

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Randomised controlled trial for the prevention of first variceal bleeding in cirrhotic patients with contraindications or intolerance to B-blockers (ligation versus no treatment)

http://isrctn.org/> ◽

10.1186/isrctn95937358 ◽

2012 ◽

Author(s):

Andrew K Burroughs

Keyword(s):

Randomised Controlled Trial ◽

Variceal Bleeding ◽

Controlled Trial ◽

Cirrhotic Patients ◽

Randomised Controlled

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Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial)

BMJ ◽

10.1136/bmj.j1455 ◽

2017 ◽

pp. j1455 ◽

Cited By ~ 25

Author(s):

Keyword(s):

Randomised Controlled Trial ◽

Postoperative Nausea ◽

Standard Treatment ◽

Controlled Trial ◽

Gastrointestinal Surgery ◽

Postoperative Nausea And Vomiting ◽

Nausea And Vomiting ◽

Randomised Controlled

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CASSETTE - clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial

10.21203/rs.2.265/v1 ◽

2019 ◽

Author(s):

Ravindra Dotel ◽

Steven YC Tong ◽

Asha Bowen ◽

Jane N Nelson ◽

Matthew VN O'Sullivan ◽

...

Keyword(s):

Staphylococcus Aureus ◽

Pilot Study ◽

Randomised Controlled Trial ◽

Standard Treatment ◽

Methicillin Resistance ◽

Controlled Trial ◽

Rate Of Change ◽

Protein Synthesis Inhibitor ◽

Open Label ◽

Randomised Controlled

Abstract Background: Exotoxins are an important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infections. However, randomised prospective data to support this is lacking. Methods: An open label, multicenter, randomised controlled trial (RCT) will compare outcome differences in severe S. aureus infection between a standard treatment (flucloxacillin/cefazolin in methicillin-susceptible S. aureus; and vancomycin/daptomycin in methicillin-resistance S. aureus) and a standard treatment plus an additional clindamycin given for 7 days. We will include a minimum of 60 participants (both adult and children) in the pilot study. Participants will be enrolled within 72 hours of an index culture. Severe infections will include septic shock, necrotising pneumonia, or multifocal and non-contiguous skin and soft tissue/osteoarticular infections. Immunosuppressed, moribund, current severe diarrhea or C. difficile infection, pregnant, and those with anaphylaxis to beta-lactams or lincosamides will be excluded. Primary outcomes measure is number of days alive and free (1 or none) of SIRS (Systemic Inflammatory Response Syndrome) within the first 14 days post randomization. Secondary outcomes measure will include all-cause mortality at 14, 42 and 90 days, time to resolution of SIRS, proportion with microbiological treatment failure, and rate of change of C-reactive protein over time. Impacts of inducible clindamycin resistance, strains types, methicillin-susceptibility, and presence of various exotoxins will also be analysed. Discussion: This study will assess the effect of adjunctive clindamycin on patient-centered outcomes in severe, toxin mediated S. aureus infections. The Pilot study will provide feasibility for a much larger RCT. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12617001416381p. Registered 06 October 2017 Keywords: Staphylococcus aureus, exotoxins, prospective studies, clindamycin, leukocidins

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An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2)

Scientific Reports ◽

10.1038/s41598-020-76184-1 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Eric P. F. Chow ◽

Kate Maddaford ◽

Jane S. Hocking ◽

Catriona S. Bradshaw ◽

Rebecca Wigan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Standard Treatment ◽

Controlled Trial ◽

Health Centre ◽

Nucleic Acid Amplification ◽

Open Label ◽

Parallel Group ◽

Randomised Controlled ◽

New Treatments ◽

Clinical Trials Registry

Abstract New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1–72%; 1/5) and in the standard treatment arm was 100% (95% CI 54–100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.

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