The effects of melatonin the occurence of on post-operative delirium in hip fracture patients a randomized, double-blind, placebo controlled trial

The effects of melatonin the occurence of on post-operative delirium in hip fracture patients a randomized, double-blind, placebo controlled trial - MAPLE A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31932

Enrollment

340

Registered

2008-08-27

Start date

2008-12-20

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychosis

Interventions

Patients will receive melatonin 3 milligrams ante noctum for five consecutive days.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 65 yrs or older Acute hospital admission for hipfracture

Exclusion criteria

Exclusion criteria: No informed consent No understanding and speaking of dutch language

Design outcomes

Primary

Measure	Time frame
The differences in the occurrence of delirium within 8 days after hospital admission for surgical repair of hip fracture between patients in the treatment arm and in the control arm.	—

Secondary

Measure	Time frame
1] Severity and duration of delirium in the treatment and in the control arm. 2] Evaluate differences in subtypes of delirium in the treatment and in the control arm. 3] Evaluate differences in length of hospital stay in the treatment and in the control arm. 4] Compare the additional use of benzodiazepines during delirium in the treatment and in the control arm. 5] Compare the total dose of haloperidol used during delirium in patients the treatment and in the control arm. 6] Evaluate the differences between in-hospital complications in the treatment and in the control arm. 7] Evaluate the differences in cognitive and functional decline at 12 months after hospital discharge between the treatment and in the control arm. 8] Evaluate the differences in mortality during hospital stay and after 12 months follow-up between the treatment and in the control arm. 9] Evaluate differences in DNA profile between delirious and non-delirious patients. Subgroup: 10] Evaluate differences in the course of melatonin concentrations between delirious and non-delirious patients receiving placebo or melatonin 3 milligram ante noctum.	—

Measure

Time frame

1] Severity and duration of delirium in the treatment and in the control arm. 2] Evaluate differences in subtypes of delirium in the treatment and in the control arm. 3] Evaluate differences in length of hospital stay in the treatment and in the control arm. 4] Compare the additional use of benzodiazepines during delirium in the treatment and in the control arm. 5] Compare the total dose of haloperidol used during delirium in patients the treatment and in the control arm. 6] Evaluate the differences between in-hospital complications in the treatment and in the control arm. 7] Evaluate the differences in cognitive and functional decline at 12 months after hospital discharge between the treatment and in the control arm. 8] Evaluate the differences in mortality during hospital stay and after 12 months follow-up between the treatment and in the control arm. 9] Evaluate differences in DNA profile between delirious and non-delirious patients. Subgroup: 10] Evaluate differences in the course of melatonin concentrations between delirious and non-delirious patients receiving placebo or melatonin 3 milligram ante noctum.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)