Trial Outcomes & Findings for Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy (NCT NCT02213900)

Results Overview

Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Haloperidol Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo
Overall Study STARTED	68	67
Overall Study COMPLETED	68	67
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Haloperidol n=68 Participants Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo n=67 Participants Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo	Total n=135 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 12.4 • n=5 Participants	59.6 years STANDARD_DEVIATION 14.0 • n=7 Participants	59.6 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.

Outcome measures

Outcome measures
Measure	Haloperidol n=68 Participants Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo n=67 Participants Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo
Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence	15 Participants	19 Participants

SECONDARY outcome

Timeframe: Up to 30 days

Test the efficacy of low dose haloperidol in reducing the number of days with delirium among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.

Outcome measures

Outcome measures
Measure	Haloperidol n=68 Participants Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo n=67 Participants Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo
Efficacy of Low-dose Haloperidol in Reducing Days With Delirium	0.3 Days with Delirium Standard Deviation 0.7	0.5 Days with Delirium Standard Deviation 0.9

SECONDARY outcome

Timeframe: Date of hospital admission through date of hospital discharge, up to 3 weeks on average.

Test the efficacy of low dose haloperidol in reducing ICU and hospital length of stay among patients who are status post esophagectomy or pneumonectomy compared to placebo.

Outcome measures

Outcome measures
Measure	Haloperidol n=68 Participants Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo n=67 Participants Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo
Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay ICU Length of Stay	2.5 Days Standard Deviation 2.2	2.8 Days Standard Deviation 10.2
Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay Overall Length of Stay	9.3 Days Standard Deviation 3.5	10.2 Days Standard Deviation 4.6

SECONDARY outcome

Timeframe: Up to 3 months after hospital discharge on average.

Test the efficacy of low dose haloperidol in reducing cognitive impairment at post-operative follow-up among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. Cognitive status is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS measures attention, language, visuospatial/constructional abilities, and memory. It is made up of 12 subtests. The subtests produce 5 index scores and a total scale score. All the subtest scores are summed to calculate a Total Index score. The Total Index score is presented. The Total Index score scale is from 0-100 with higher scores indicating less cognitive impairment.

Outcome measures

Outcome measures
Measure	Haloperidol n=68 Participants Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo n=67 Participants Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo
Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up Baseline RBANS Total Score	31.7 Units on a scale Standard Deviation 27.6	30.1 Units on a scale Standard Deviation 22.8
Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up 3 Month RBANS Total Score	31.8 Units on a scale Standard Deviation 30.1	22.7 Units on a scale Standard Deviation 23.2

Adverse Events

Haloperidol

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Haloperidol n=68 participants at risk Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days	Placebo n=67 participants at risk Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days. Placebo
General disorders Death	0.00% 0/68	1.5% 1/67 • Number of events 1
General disorders Life Threatening Episode	1.5% 1/68 • Number of events 1	1.5% 1/67 • Number of events 1
General disorders Inpatient or Prolonged Current Hospitalization	2.9% 2/68 • Number of events 2	0.00% 0/67

Other adverse events

Adverse event data not reported

Additional Information

Babar Khan, MD

Indiana University

Phone: 317-274-9132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place