scholarly journals Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC): a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bradley Wibrow ◽  
F. Eduardo Martinez ◽  
Andrew Ford ◽  
Erin Kelty ◽  
Kevin Murray ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Statistical Analysis ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Brain Dysfunction ◽  
Primary Objective ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Randomised Controlled

Abstract Rationale Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sleep is important in the prevention and management of delirium. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle. It is possible that melatonin supplementation in intensive care improves sleep and prevents delirium. Methods and design The ‘Prophylactic Melatonin for Delirium in Intensive Care’ study is a multi-centre, randomised, double-blinded, placebo-controlled trial. The primary objective of this study is to determine whether melatonin given prophylactically decreases delirium in critically ill patients. A total of 850 ICU patients have been randomised (1:1) to receive either melatonin or a placebo. Participants were monitored twice daily for symptoms of delirium. Results This paper and the attached additional files describe the statistical analysis plan (SAP) for the trial. The SAP has been developed and submitted for publication before the database has been locked and before the treatment allocation has been unblinded. The SAP contains details of analyses to be undertaken, which will be reported in the primary and secondary publications. Discussion The SAP details the analyses that will be done to avoid bias coming from knowledge of the results in advance. This trial will determine whether prophylactic melatonin administered to intensive care unit patients helps decrease the rate and the severity of delirium. Trial registration Australian and New Zealand Clinical Trial Registry (ANZCTR) ACTRN1261600043647, registration date: 06 April 2016. WHO Trial Number – U1111-1175-1814

scholarly journals Statistical Analysis Plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit (SuDDICU) study

2020 ◽  
Author(s):  
Laurent Billot ◽  
John Myburgh ◽  
Fiona Goodman ◽  
Simon Finfer ◽  
Ian Seppelt ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Statistical Analysis ◽  
Digestive Tract ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Statistical Analysis Plan ◽  
Selective Decontamination ◽  
Cluster Randomised ◽  
Randomised Controlled

SuDDICU is an international, multicentre, cross-over, cluster randomised controlled trial comparing the effect of selective decontamination of the digestive tract to usual care on hospital mortality in patients receiving mechanical ventilation in the intensive care unit. This manuscript presents the pre-specified statistical analysis plan (SAP) for the SuDDICU trial. The SAP was written without knowledge of the effect of the intervention.

scholarly journals The effect of rectal progesterone on latency period as well as maternal and prenatal outcome between 24 to 33 weeks

2015 ◽  
Vol 2 (4) ◽  
pp. 97
Author(s):  
Fadwah Tahir ◽  
Mohammed Badawi ◽  
Abdulelah Nuqali ◽  
Yasir Katib ◽  
Irfanallah Muhammad Siddiqui ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Randomized Clinical Trials ◽  
Post Partum ◽  
Controlled Trial ◽  
Latency Period ◽  
Neonatal Morbidity ◽  
Primary Objective ◽  
Intrauterine Fetal Death

Preterm Premature Rupture Of Membranes (PPROM) is directly linked to prematurity associated with severe neonatal morbidity and mortality. Randomized clinical trials have shown that weekly injections of 17-alpha-hydroxyprogesterone (17P) or daily vaginal progesterone application decreases the number of preterm deliveries, particularly for women with a history of preterm delivery or those with a shortened cervix. However, no studies have yet been conducted to prove or disprove the effect of rectal progesterone on latency period. To address this issue,<strong> </strong>we will conduct a multicenter randomized triple-blind controlled trial of 216 participants (108 in each group) from January 1, 2016 to August 31, 2016. Inclusion criteria, exclusion criteria, data collection procedure, data analysis, and assessment of safety procedures are explained in the study protocol.<strong> </strong>The primary objective will be to determine the effect of rectal progesterone on the latency period in PPROM. The secondary objective will be to study the effect of rectal progesterone on maternal outcomes of hospitalization, intensive care unit admission, chorioamnionitis, post-partum hemorrhage, post-partum pyrexia, endometritis, and maternal death. In addition, we will evaluate prenatal birth weight, Apgar score, neonatal morbidity, duration of neonatal intensive care unit stay, intrauterine fetal death, and neonatal death associated with PPROM.

scholarly journals The Agents Intervening against Delirium in the Intensive Care Unit Trial (AID‐ICU trial): A detailed statistical analysis plan

2020 ◽  
Vol 64 (9) ◽  
pp. 1357-1364
Author(s):  
Nina Andersen‐Ranberg ◽  
Lone M. Poulsen ◽  
Anders Perner ◽  
Jørn Wetterslev ◽  
Ole Mathiesen ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Detailed Statistical Analysis

scholarly journals Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
F. Eduardo Martinez ◽  
Matthew Anstey ◽  
Andrew Ford ◽  
Brigit Roberts ◽  
Miranda Hardie ◽  
...  
Keyword(s):  
Intensive Care ◽  
Critically Ill ◽  
Controlled Trial ◽  
Study Drug ◽  
Assessment Method ◽  
Trial Registration ◽  
Morbidity And Mortality ◽  
Controlled Study ◽  
Clinical Trial Registry ◽  
Icu Discharge

Abstract Background Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances, usually due to illness. It occurs commonly in the intensive care unit (ICU), and it is associated with greater morbidity and mortality. It is likely that disturbances of sleep and of the day-night cycle play a significant role. Melatonin is a naturally occurring, safe and cheap hormone that can be administered to improve sleep. The main aim of this trial will be to determine whether prophylactic melatonin administered to critically ill adults, when compared with placebo, decreases the rate of delirium. Methods This trial will be a multi-centre, randomised, placebo-controlled study conducted in closed ICUs in Australia. Our aim is to enrol 850 adult patients with an expected ICU length of stay (LOS) of 72 h or more. Eligible patients for whom there is consent will be randomised to receive melatonin 4 mg enterally or placebo in a 1:1 ratio according to a computer-generated randomisation list, stratified by site. The study drug will be indistinguishable from placebo. Patients, doctors, nurses, investigators and statisticians will be blinded. Melatonin or placebo will be administered once per day at 21:00 until ICU discharge or 14 days after enrolment, whichever occurs first. Trained staff will assess patients twice daily to determine the presence or absence of delirium using the Confusion Assessment Method for the ICU score. Data will also be collected on demographics, the overall prevalence of delirium, duration and severity of delirium, sleep quality, participation in physiotherapy sessions, ICU and hospital LOS, morbidity and mortality, and healthcare costs. A subgroup of 100 patients will undergo polysomnographic testing to further evaluate the quality of sleep. Discussion Delirium is a significant issue in ICU because of its frequency and associated poorer outcomes. This trial will be the largest evaluation of melatonin as a prophylactic agent to prevent delirium in the critically ill population. This study will also provide one of the largest series of polysomnographic testing done in ICU. Trial registration Australian New Zealand Clinical Trial Registry (ANZCTR) number: ACTRN12616000436471. Registered on 20 December 2015.

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