Evidence map›Paper›PMID 20095068›Full record

Trial reportCritical care medicine2010

Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo-controlled trial.

Timothy D Girard, Pratik P Pandharipande, Shannon S Carson, Gregory A Schmidt, Patrick E Wright, Angelo E Canonico, Brenda T Pun, Jennifer L Thompson, Ayumi K Shintani, Herbert Y Meltzer and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 141 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 18 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 18 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Antipsychotics for treatment of delirium in hospitalised non-ICU patients.The Cochrane database of systematic reviews · 2018
    Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Guideline
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Trial
  20. Trial

81 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Timothy D GirardDepartment of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA. timothy.girard@vanderbilt.edu
Pratik P Pandharipande
Shannon S Carson
Gregory A Schmidt
Patrick E Wright
Angelo E Canonico
Brenda T Pun
Jennifer L Thompson
Ayumi K Shintani
Herbert Y Meltzer
Gordon R Bernard
Robert S Dittus
E Wesley Ely
MIND Trial Investigators

Funding

The MIND ICU StudyR01AG027472 · NIA · VANDERBILT UNIVERSITY · PI ELY, E WESLEY · 2006 to 2010
$3.0M
PATHOPHYSIOLOGY OF THE PULMONARY MICROCIRCULATION:T32HL007123 · NHLBI · VANDERBILT UNIVERSITY · PI BERNARD, GORDON R. · 1985 to 2004
$2.7M
NHLBI NIH HHS HL007123NHLBI NIH HHS T32 HL007123NIA NIH HHS AG027472NIA NIH HHS R01 AG027472
6 · The paper itself

Abstract

objectiveTo demonstrate the feasibility of a placebo-controlled trial of antipsychotics for delirium in the intensive care unit and to test the hypothesis that antipsychotics would improve days alive without delirium or coma.

designRandomized, double-blind, placebo-controlled trial.

settingSix tertiary care medical centers in the US. PATIENTS: One hundred one mechanically ventilated medical and surgical intensive care unit patients.

interventionPatients were randomly assigned to receive haloperidol or ziprasidone or placebo every 6 hrs for up to 14 days. Twice each day, frequency of study drug administration was adjusted according to delirium status, level of sedation, and side effects. MEASUREMENTS AND MAIN OUTCOMES: The primary end point was the number of days patients were alive without delirium or coma. During the 21-day study period, patients in the haloperidol group spent a similar number days alive without delirium or coma (median [interquartile range], 14.0 [6.0-18.0] days) as did patients in the ziprasidone (15.0 [9.1-18.0] days) and placebo groups (12.5 [1.2-17.2] days; p = 0.66). No differences were found in secondary clinical outcomes, including ventilator-free days (p = .25), hospital length of stay (p = .68), and mortality (p = .81). Ten (29%) patients in the haloperidol group reported symptoms consistent with akathisia, compared with six (20%) patients in the ziprasidone group and seven (19%) patients in the placebo group (p = .60), and a global measure of extrapyramidal symptoms was similar between treatment groups (p = .46).

conclusionsA randomized, placebo-controlled trial of antipsychotics for delirium in mechanically ventilated intensive care unit patients is feasible. Treatment with antipsychotics in this limited pilot trial did not improve the number of days alive without delirium or coma, nor did it increase adverse outcomes. Thus, a large trial is needed to determine whether use of antipsychotics for intensive care unit delirium is appropriate.

Indexed as

Intensive Care UnitsAdultAgedAntipsychotic AgentsDeliriumDouble-Blind MethodFemaleHaloperidolHumansLength of StayMaleMiddle AgedPiperazinesPostoperative ComplicationsPsychiatric Status Rating ScalesRespiration, ArtificialAntipsychotic AgentsHaloperidolPiperazinesThiazolesziprasidone

Identifiers

PMID20095068
PMCPMC3645269

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.