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Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.
The recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. As a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-dialysis recovery group | Other | Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-dialysis Recovery Time | Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account. | Up to 7 days |
| Number of Participants With Intradialytic Hypotension | It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention. | Up to 7 days |
| Rate of Dialysis Symptoms | It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms. | Up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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Being on HD for 4 hours a day on 3 days per week for at least 6 months and 18 years or older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Demiroglu Bİlim University | Istanbul | Sisli | 34360 | Turkey (Türkiye) | ||
| Demiroglu Bilim University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22941875 | Background | Bossola M, Di Stasio E, Antocicco M, Silvestri P, Tazza L. Variables associated with time of recovery after hemodialysis. J Nephrol. 2013 Jul-Aug;26(4):787-92. doi: 10.5301/jn.5000198. Epub 2012 Aug 31. | |
| 28419668 | Background | Bossola M, Marzetti E, Di Stasio E, Monteburini T, Cenerelli S, Mazzoli K, Parodi E, Sirolli V, Santarelli S, Ippoliti F, Nebiolo PE, Bonomini M, Melatti R, Vulpio C. Prevalence and associated variables of post-dialysis fatigue: Results of a prospective multicentre study. Nephrology (Carlton). 2018 Jun;23(6):552-558. doi: 10.1111/nep.13059. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-dialysis Recovery Group | Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-dialysis Recovery Group | Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-dialysis Recovery Time | Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account. | Posted | Mean | Standard Deviation | minutes | Up to 7 days |
|
|
up to 4 weeks
Side effects/other adverse events were not monitored
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-dialysis Recovery Group | Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurten OZEN | Demiroglu Bilim University | +90 212 213 64 86 | ozenurten@yahoo.com.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2020 | May 12, 2020 | Prot_SAP_000.pdf |
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| Istanbul |
| 34384 |
| Turkey (Türkiye) |
| 30860667 | Background | Davenport A, Guirguis A, Almond M, Day C, Chilcot J, Wellsted D, Farrington K. Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival. Hemodial Int. 2019 Jul;23(3):288-296. doi: 10.1111/hdi.12743. Epub 2019 Mar 12. |
| 33497021 | Derived | Ozen N, Cepken T, Tosun B. Do biochemical parameters and intradialytic symptoms affect post-dialysis recovery time? A prospective, descriptive study. Ther Apher Dial. 2021 Dec;25(6):899-907. doi: 10.1111/1744-9987.13624. Epub 2021 Feb 8. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Primary | Number of Participants With Intradialytic Hypotension | It is defined in the European Best Practice Guideline (EBPG) as a decrease of 20 mmHg or more in the systolic blood pressure or 10 mmHg or more in the mean arterial blood pressure together with symptoms requiring nursing intervention. | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
| Primary | Rate of Dialysis Symptoms | It was identified with Dialysis Symptom Index (DSI). DSI consists of 30 items. We queried the subjects regarding symptoms in the last 7 days. The effect was evaluated with a Likert type scale from 0 to 4, representing "not at all" to "significantly". The total score of the DSI ranges from 0 to 150. A score of zero reflects no symptoms while increasing total scores reflect increasing effects of the symptoms. | Posted | Mean | Standard Deviation | score on a scale | Up to 7 days |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 0 |
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