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Morbidity and Mortality Among Dialysis Patients After Treatment for Depression

1. března 2007 aktualizováno: Portland VA Medical Center

Morbidity and Mortality among Dialysis Patients after Treating Depression

Objectives

Our investigation has two objectives:

  1. To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported.
  2. To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management.

Plan and Methods

This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment.

Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,

Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects.

Findings to date

We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected.

Significance

We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.

Přehled studie

Postavení

Neznámý

Podmínky

Detailní popis

Morbidity and Mortality among Dialysis Patients after Treating Depression

Objectives

Our investigation has two objectives:

  1. To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported.
  2. To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management.

Plan and Methods

This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment.

Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,

Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects.

Findings to date

We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected.

Significance

We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.

Typ studie

Pozorovací

Zápis

350

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Oregon
      • Portland, Oregon, Spojené státy, 97239
        • Nábor
        • Portland VA MC
        • Kontakt:
          • suzanne watnick

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • ESRD age > 18

Exclusion Criteria:

  • non english speaking, another psychiatric dx aside from depression

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: suzanne watnick, MD, PVAMC physician

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2004

Dokončení studie

1. června 2010

Termíny zápisu do studia

První předloženo

1. března 2007

První předloženo, které splnilo kritéria kontroly kvality

1. března 2007

První zveřejněno (Odhad)

2. března 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

2. března 2007

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. března 2007

Naposledy ověřeno

1. března 2007

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 00898

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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