Evidence map›Paper›PMID 29482596›Full record

ArticleTrials2018

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe): a phase IV multicenter, randomized, placebo-controlled, double-blind clinical trial of ketamine versus haloperidol for prevention of postoperative delirium.

Harriet Riegger, Alexa Hollinger, Burkhardt Seifert, Katharina Toft, Andrea Blum, Tatjana Zehnder, Martin Siegemund

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02433041 (Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 25% of its field
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.

NCT02433041 phase4completednot on this map

Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2013 to 2018Enrolled200ConditionsPostoperative DeliriumArmsHaloperidol, Ketamine, Haloperidol + Ketamine, Saline solution (NaCl 0.9%)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. 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

7 authors at 3 institutions in 1 country.

Harriet RieggerDepartment for Anesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.
Alexa HollingerDepartment for Anesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland. alexa.hollinger@usb.ch.ORCID http://orcid.org/0000-0001-6799-1652
Burkhardt SeifertEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Katharina ToftDepartment for Anesthesia, Intensive Care and Emergency Medicine, See-Spital, Horgen and Kilchberg branches, Horgen and Kilchberg, Switzerland.
Andrea BlumDepartment for Anesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.
Tatjana ZehnderDepartment for Anesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.
Martin SiegemundDepartment for Anesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, Switzerland.
University Hospital of Basel · CHSanatorium Kilchberg · CHUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDelirium is a neurobehavioural syndrome that frequently develops in the postoperative setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 10-80%. Delirium was first described more than half a century ago in the cardiac surgery population, where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population. This long-term experience with delirium suggests a high socioeconomic burden and has been a focus of many studies. Due to the multifactorial origin of delirium, we have several but no incontestable options for prevention and symptomatic treatment. Overall, delirium represents a high burden not only for patient and family members, but also for the medical care team that aims to prevent postoperative delirium to avoid serious consequences associated with it. The purpose of this study is to determine whether postoperative delirium can be prevented by the combination of established preventive agents. In addition, measured levels of pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100β will be used to investigate dynamics of these parameters in delirious and non-delirious patients after surgery. METHODS/

designThe Baden PRIDe Trial is an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial for the prevention of delirium with haloperidol, ketamine, and the combination of both vs. placebo in 200 patients scheduled for surgery. We would like to investigate superiority of one of the three treatment arms (i.e., haloperidol, ketamine, combined treatment) to placebo. DISCUSSION: There is limited but promising evidence that haloperidol and ketamine can be used to prevent delirium. Clinical care for patients might improve as the results of this study may lead to better algorithms for the prevention of delirium.

trial registrationClinicalTrials.gov, NCT02433041 . Registered on 7 April 2015. Swiss National Clinical Trial Portal, SNCTP000001628. Registered on 9 December 2015.

Indexed as

Anesthetics, DissociativeAntipsychotic AgentsClinical Trials, Phase IV as TopicDeliriumDouble-Blind MethodHaloperidolHumansIncidenceKetamineMulticenter Studies as TopicPostoperative ComplicationsRandomized Controlled Trials as TopicRisk FactorsSwitzerlandTime FactorsTreatment OutcomeAnesthetics, DissociativeAntipsychotic AgentsHaloperidolKetamineDelirium preventionDOSHaloperidolICDSCKetamineMMSENSENu-DESCPostoperative deliriumRandomised clinical trialS100β

Identifiers

PMID29482596
PMCPMC5828327
OpenAlexW2790074616

What OpenQuestion holds

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Registered trials

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.