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The goal of this study is to evaluate interdialytic blood pressure changes of the patients in chronic hemodialysis.
The main question to be answered is: What is the relative importance of weight gain, the renin angiotensin system, the sympathetic nervous system and inflammatory immune reactivity in the interdialytic hypertension of patients in chronic hemodialysis, The participants will have hemodynamic evaluation (cardiac output and peripheral vascular resistance) at the end of dialysis, ambulatory monitoring of blood pressure in the interdialytic period. Serum samples will be collected at the end of dialysis and before the start of the next dialysis, 2-3 days later.
This is a prospective observational study that will study stable patients in the chronic hemodialysis program of the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" (INCMNSZ) patients. There will be no modifications in the dialysis prescriptions or treatments and the patients with inclusion criteria will be studied after and before their usual hemodialysis sesion.
All serum levels will be determined by commercial ELISA kits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | There will be no intervention. Group A will be patients with ABP (ambulatory blood pressure) <130/80 mmHg (controlled hypertension) |
| |
| Group B | There will be no intervention. Group B will be patients with ABP 130-139/80-89 mmHg (insufficiently controled hypertension) |
| |
| Group C | There will be no intervention. Group C will be patients with ABP ≥140/90 mmHg (uncontrolled hypertension) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There will be no intervention | Other | There will be no intervention. This is an observational studies and 3 groups will be organized depending on the level of ABP in the interdialytic period |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output | Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area. | Each participant was studied once 1-3 hours after dialysis ended |
| Interdialytic Weight Change | The weight was determined in 2 ocassions: first, immediately after dialysis and second, 2-3 days later, before the next dialysis. The weight change in this interval is expressed as percentage change of the second measure in relation to the first measure. | Interdialytic weight change was studied once, by the difference between the weight at the end of dialysis and the weight 2-3 days later, before the next dialysis. |
| Systemic Vascular Resistance | Systemic vascular resistance was calculated using MediCalcR using the mean arterial pressure (MAP), the central venous pressure (CVP) anf the cardiac output (CO) and the equation: SVR=[(MAP-CVP)x79.92]/CO. Cardiac output (CO= systolic volume x heart rate) and central venous pressure were determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer. Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area. | Systemic vascular resistance was determined once in the participants 1-3 hours after dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Angiotensin II Serum Levels | Angiotensin serum levels (pg/ml) were determined once at the end of the interdialytic period, before dialysis, using ELISA (my BioSource Cat.# MBS703599) | Each participant was studied once. Serum samples taken before dialysis |
| Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR) |
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Inclusion Criteria:
Exclusion Criteria:
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Participantes will be patients in the chronic hemodialysis program of the INCMNSZ assigned to the groups depending on the ambulatory blood pressure (ABP) monitoring: Group A (TA < 130/80 mmHg), group B (TA 130-139/80-89 mmHg and group C (TA > 140mmHg)
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| Name | Affiliation | Role |
|---|---|---|
| Bernardo RODRIGUEZITURBE, MD, PhD | Department of Nephrology, Instituto Nacional de Ciencias Medicas y Nutrición "Salvador Zubirán" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26644240 | Background | Rodriguez-Iturbe B. Autoimmunity in the Pathogenesis of Hypertension. Hypertension. 2016 Mar;67(3):477-83. doi: 10.1161/HYPERTENSIONAHA.115.06418. Epub 2015 Dec 7. No abstract available. | |
| 32712185 | Background | Fay KS, Cohen DL. Resistant Hypertension in People With CKD: A Review. Am J Kidney Dis. 2021 Jan;77(1):110-121. doi: 10.1053/j.ajkd.2020.04.017. Epub 2020 Jul 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (ABP < 130/80 mmHg) | Constituted by15 patients in the chronic hemodialisis program with ABP < 130/80 mmHg, and we measured interdialytic weight gain, cardiac output, systemic vascular resistance, blood pressure changes, interdialytic ambulatory blood pressure monitoring (ABPM) . Serum levels of angiotensin II, norepinephrin, copeptin and the ratio of monocytes + neutrophils / linphocytes (MNLR) |
| FG001 | Group B (ABP 130-139/80-89 mmHg) | This group was constituted by patients with ABP 130-139/80-89 mmHg. They were 7 patients in the chronic hemodialisis program, and we measured blood pressure changes, interdialysis ambulatory blood pressure monitoring (ABPM) and interdialisis weight gain. Serum levels of angiotensin II, norepinephrin, copeptin and the ratio of monocytes + neutrophils / lymphocytes (MNLR). |
| FG002 | Group C (ABP ≥ 140/90 mmHg) | Constituted by 10 patients in the chronic hemodialisis program, with ABP ≥ 140/90 mmHg. We measured blood pressure changes, interdialysis ambulatory blood pressure monitoring (ABPM) and interdialisis weight gain. Serum levels of angiotensin II, norepinephrin, copeptin, and the ratio of monocytes + neutrophils / linphocytes (MNLR) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Inclusion criteria: >18 years, >6 months in chronic hemodialysis, estable clinical conditions with no evidence of infection, or changes in medications, dialysis characteristics are not modified in the last months and sign informed consent to participate in the study.
Exclusion criteria: previous nephrectomy, administration of eritropoyetin at the end of dialysis at the end of the stydu, participation of patient in other study, requiered a clinical intervention and incomplete collection of data
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (ABP < 130/80 mmHg) | We observed 15 patients in the chronic hemodialysis program with ABP < 130/80 mmHg, and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring and interdialytic weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, and the ratio of monocytes + neutrophils / lymphocytes (MNLR). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cardiac Output | Cardiac output (systolic volume x heart rate) was determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area. | Patients were mexicans of both sexes of mixed (undetermined) race and ethnicity | Posted | Mean | Standard Error | L/min | Each participant was studied once 1-3 hours after dialysis ended |
|
The observational study was performed through 1 to 3 days and no adverse events were reported.
The observational study was performedThe observational study was performed through 1 to 3 days and no adverse events were reported or death.
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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 | Group 1 (TA < 130mmHg) | We observed 15 patients in the chronic hemodialysis program, and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring (ABPM) and interdialytic weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, tumor necrosis factor alpha (TNF-a), and the ratio of monocytes + neutrophils / lymphocytes. |
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1) Potential effects of antihypertension drug therapy (observational study) may not be completely discarded. 2)Only 32 patients in only one recruitment center. Further studies are required to validate the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernardo Rodriguez Iturbe | Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran" | 9991490061 | brodrigueziturbe@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2025 | Sep 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2025 | Sep 11, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2025 | Sep 11, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Serum samples: Serum levels of angiotensin II, norepinephrine, copeptin, Peripheral blood: Ratio of monocytes + neutrophils / lymphocytes (MNLR).
Monocyte+Neutrophile/lymphocyte ratio obtained from peripheral blood counts in samples taken before dialysis (following the end of the interdialytic period). |
| Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period). |
| Serum Norepinephrine Levels | Interdialytic serum norepinephrine levels determined in blood samples obtained before dialysis (end of interdialytic period) using ELISA (ABCAM, Cat. # AB287789); | Each participant was studied once. Serum samples taken before dialysis |
| Serum Copeptin Levels | The copeptin levels (surrogate for arginine vasopressin) were measured before dialyisis (end of the interdialytic period) using ELISA (Bio-techne/NovusBiological, Cat, # NBP2-69822) | Each participant was studied once. Serum samples taken before dialysis |
| Hypertension Phenotypes | Interdialytic ambulatory blood pressure determined during 24-44 hours using Space Labs Health Care, model 90217A and Contec ABPM50 equipment. Determinations every 30 minutes during daytime and every hour during the night. We are here reporting the phenotypes in the total number of participants (n=32) instead that in each group (groups A n=15, B n=7 and C n=10) because our main interest was to determine the incidence of each phenotyte in stable patients treated with chronic dialysis, rather than in each group that, individually, had few patients | Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysis |
| 26125645 | Background | Abais-Battad JM, Rudemiller NP, Mattson DL. Hypertension and immunity: mechanisms of T cell activation and pathways of hypertension. Curr Opin Nephrol Hypertens. 2015 Sep;24(5):470-4. doi: 10.1097/MNH.0000000000000146. |
| 20507951 | Background | Agarwal R, Weir MR. Dry-weight: a concept revisited in an effort to avoid medication-directed approaches for blood pressure control in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Jul;5(7):1255-60. doi: 10.2215/CJN.01760210. Epub 2010 May 27. |
| 28566539 | Background | Rodriguez-Iturbe B, Pons H, Johnson RJ. Role of the Immune System in Hypertension. Physiol Rev. 2017 Jul 1;97(3):1127-1164. doi: 10.1152/physrev.00031.2016. |
| 15086894 | Background | Neumann J, Ligtenberg G, Klein II, Koomans HA, Blankestijn PJ. Sympathetic hyperactivity in chronic kidney disease: pathogenesis, clinical relevance, and treatment. Kidney Int. 2004 May;65(5):1568-76. doi: 10.1111/j.1523-1755.2004.00552.x. |
| 4561117 | Background | Kim KE, Onesti G, Schwartz AB, Chinitz JL, Swartz C. Hemodynamics of hypertension in chronic end-stage renal disease. Circulation. 1972 Sep;46(3):456-64. doi: 10.1161/01.cir.46.3.456. No abstract available. |
| 8957032 | Background | Buckalew VM Jr, Berg RL, Wang SR, Porush JG, Rauch S, Schulman G. Prevalence of hypertension in 1,795 subjects with chronic renal disease: the modification of diet in renal disease study baseline cohort. Modification of Diet in Renal Disease Study Group. Am J Kidney Dis. 1996 Dec;28(6):811-21. doi: 10.1016/s0272-6386(96)90380-7. |
| 15250921 | Background | Saad E, Charra B, Raj DS. Hypertension control with daily dialysis. Semin Dial. 2004 Jul-Aug;17(4):295-8. doi: 10.1111/j.0894-0959.2004.17330.x. |
| BG001 |
| Group B (ABP 130-139/80-89 mmHg) |
We observed 7 patients in the chronic hemodialysis program with ABP 130-139/80-89 mmHg , and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring and interdialysis weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, and the ratio of monocytes + neutrophils / lymphocytes (MNLR). |
| BG002 | Group C (ABP ≥ 140/90 mmHg) | We observed 10 patients in the chronic hemodialysis program with ABP ≥ 140/90 mmHg and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring and interdialytic weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, and the ratio of monocytes + neutrophils / lymphocytes (MNLR). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Region of Enrollment | All parcipants were from Mexico City. Volunteers from the chronic hemodialysis program | Number | participants |
|
| Cardiac output | Cardiac output (CO) =systolic volume x heart rate. Determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer . Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area. | Mean | Standard Deviation | L/min |
|
| Hypertension Phenotypes | Definitions: normal dippers when the blood pressure falls at night between 10-20% non- dippers when the blood pressure falls at night less than 10% reverse-dippers when the blood pressures increases during sleep instead of falling. extreme dippers when the blood pressure falls at night more than 20% | Number of participants indicate the participants analized in groups A, B and C (all members of each group (total of 32 participantes). The number of deepers, non-deepers, extreme deepers and reverse deepers was different in each group but the total number is also 32 | Count of Participants | Participants | No |
|
| OG002 | Group C | Patients with ABP ≥140/90 mmHg |
|
|
| Primary | Interdialytic Weight Change | The weight was determined in 2 ocassions: first, immediately after dialysis and second, 2-3 days later, before the next dialysis. The weight change in this interval is expressed as percentage change of the second measure in relation to the first measure. | Patients were mexicans of both sexes and mixed (undetermined) race and ethnicity | Posted | Mean | Standard Error | percentage change | Interdialytic weight change was studied once, by the difference between the weight at the end of dialysis and the weight 2-3 days later, before the next dialysis. |
|
|
|
| Primary | Systemic Vascular Resistance | Systemic vascular resistance was calculated using MediCalcR using the mean arterial pressure (MAP), the central venous pressure (CVP) anf the cardiac output (CO) and the equation: SVR=[(MAP-CVP)x79.92]/CO. Cardiac output (CO= systolic volume x heart rate) and central venous pressure were determined by 2 experienced observers using a Siemens Acuson P500 ultrasound equipment with a phased array transducer. Systolic volume was calculated with the velocity time integral of the flow of the left ventricle outflow tract of the aortic area. | All the participants were mexicans of both sexes and mixed (undetermined) race and ethnicity | Posted | Mean | Standard Error | dynes*s/cm˄5 | Systemic vascular resistance was determined once in the participants 1-3 hours after dialysis |
|
|
|
| Secondary | Angiotensin II Serum Levels | Angiotensin serum levels (pg/ml) were determined once at the end of the interdialytic period, before dialysis, using ELISA (my BioSource Cat.# MBS703599) | The participants were mexican of both sexes and mixed (undetermined) race and ethnicity | Posted | Mean | Standard Error | pg/ml | Each participant was studied once. Serum samples taken before dialysis |
|
|
|
| Secondary | Monocyte+Neutrophiles/Lymphocyte Ratio (MNLR) | Monocyte+Neutrophile/lymphocyte ratio obtained from peripheral blood counts in samples taken before dialysis (following the end of the interdialytic period). | Participants were mexicans of mixed (undetermined) race | Posted | Mean | Standard Error | ratio | Each participant was studied once. Blood samples taken before dialysis (following the end of the interdialytic period). |
|
|
|
| Secondary | Serum Norepinephrine Levels | Interdialytic serum norepinephrine levels determined in blood samples obtained before dialysis (end of interdialytic period) using ELISA (ABCAM, Cat. # AB287789); | The studies were done at the end of the interdialytic period. Samples taken before the next dialysis | Posted | Median | Inter-Quartile Range | pg/ml | Each participant was studied once. Serum samples taken before dialysis |
|
|
|
| Secondary | Serum Copeptin Levels | The copeptin levels (surrogate for arginine vasopressin) were measured before dialyisis (end of the interdialytic period) using ELISA (Bio-techne/NovusBiological, Cat, # NBP2-69822) | Mexican mixed population of undetermined race | Posted | Mean | Standard Error | pmol/L | Each participant was studied once. Serum samples taken before dialysis |
|
|
|
| Secondary | Hypertension Phenotypes | Interdialytic ambulatory blood pressure determined during 24-44 hours using Space Labs Health Care, model 90217A and Contec ABPM50 equipment. Determinations every 30 minutes during daytime and every hour during the night. We are here reporting the phenotypes in the total number of participants (n=32) instead that in each group (groups A n=15, B n=7 and C n=10) because our main interest was to determine the incidence of each phenotyte in stable patients treated with chronic dialysis, rather than in each group that, individually, had few patients | The number of dippers, non-dippers, extreme dippers and reverse dippers were studied in all participants (n=32) . | Posted | Count of Participants | Participants | Each participant was studied once. Ambulatory blood pressure was monitored or 24-44 hours during the interdialytic perdiod starting 1-3 hours after dialysis |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Group 2 (TA 130-139mmHg) | We observed 7 patients in the chronic hemodialysis program, and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring (ABPM) and interdialyticweight gain. Serum levels of angiotensin II, norepinephrine, copeptin, TNF-a, and the ratio of monocytes + neutrophils / lymphocytes. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Group 3 (TA > 140) | We observed 10 patients in the chronic hemodialysis program, and we measured blood pressure changes, interdialytic ambulatory blood pressure monitoring (ABPM) and interdialytic weight gain. Serum levels of angiotensin II, norepinephrine, copeptin, TNF-a, and the ratio of monocytes + neutrophils / lymphocytes. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Male |
|
| Non-dippers |
|
| Extreme Dippers |
|
| Reverse-dippers |
|