MAPLE A (Melatonin Against PLacebo in Elderly patients).

The Effects of melatonin versus placebo on the occurence of delirium in hip fracture patients - a randomized, placebo controlled, double-blind trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22152

Enrollment

340

Registered

2008-12-02

Start date

2008-11-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Delirium Hip Fracture Elderly

Interventions

Patients included in the MAPLE A stduy will be assigned to receive either melatonin 3 mg or placebo for 5 consequtive days. Daily check-up will take place for evaluation of delirious symptoms, using t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 65 years or older; 2. Acute admission for surgical repair of hip-fracture; 3. Patiente must be willing and medically able to take the study medication; 4. Patients must be able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who can't speak / understand Dutch; 2. Patients transferred for surgical repair from another hospital.

Design outcomes

Primary

Measure	Time frame
Delirium diagnosed within 8 days after start of the study medication.	—

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 the treatment and in the control arm. 6. Evaluate differences in in-hospital complications, defined as hospital related infections, decubitus and malnutrition in patients the treatment and in the control arm. 7. Evaluate differences in cognitive and functional decline at 12 months after hospital discharge in the treatment and in the control arm. 8. Evaluate differences in mortality during hospital stay and after 12 months follow-up in the treatment and in the control arm. 9. Evaluate differences in DNA profile in delirious and non-delirious patients.	—

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 the treatment and in the control arm. 6. Evaluate differences in in-hospital complications, defined as hospital related infections, decubitus and malnutrition in patients the treatment and in the control arm. 7. Evaluate differences in cognitive and functional decline at 12 months after hospital discharge in the treatment and in the control arm. 8. Evaluate differences in mortality during hospital stay and after 12 months follow-up in the treatment and in the control arm. 9. Evaluate differences in DNA profile in delirious and non-delirious patients.

—

Contacts

Public ContactS.E. Rooij, de

Academic Medical Centre Amsterdam Internal-Geriatric Department Academic Medical Center Meibergdreef 9

(31)205669325

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)