RBR-7gwwxzg Effect of infrared light on chronic renal patients undergoing hemodialysis and conservative treatment

Date of registration: 01/07/2025 ^(mm/dd/yyyy)
Last approval date : 01/07/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1286-7383

• Public title:

  en

  Effect of infrared light on chronic renal patients undergoing hemodialysis and conservative treatment

  pt-br

  Efeito da luz infravermelha em paciente renal crônico em hemodiálise e tratamento conservador

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 62981922.5.0000.5492
    Issuing authority: Plataforma brasil
  • 5.797.915
    Issuing authority: Comitê de ética e pesquisa da universidade anhembi morumbi

Sponsors

• Primary sponsor: Universidade Anhembi Morumbi
• Secondary sponsor:
  • Institution: Hospital Regional do Baixo Amazonas Dr. Waldemar Penna
• Supporting source:
  • Institution: Universidade Anhembi Morumbi

Health conditions

• Health conditions:

  en

  Chronic Kidney Disease

  pt-br

  Doença Renal Crônica

• General descriptors for health conditions:

  en

  C23.550.291.500 Kidney Disease

  pt-br

  C23.550.291.500 Doença Renal

• Specific descriptors:

  en

  C23.550.291.500.906 Chronic Kidney Disease

  pt-br

  C23.550.291.500.906 Doença Renal Crônica

Interventions

• Interventions:

  en

  This is a prospective, cross-sectional, analytical and descriptive study, with a qualitative approach. The study was carried out in a renal replacement therapy center. Two groups were formed, the first group consisted of 15 renal patients undergoing renal replacement therapy. The second group consisted of 09 renal patients undergoing conservative treatment. Patients were selected according to inclusion criteria. Both groups underwent the same Low Intensity Light Therapy protocol, using an LED vest with 300 lights (940 nm); patients were irradiated for 15 minutes a day, 3 times a week, for 60 days. Before patients started Low Intensity Light Therapy, control tests were performed such as complete blood count, urea, creatinine, potassium, calcium, phosphorus, serum iron, serum ferritin, transferrin and TGP, with the aim of evaluating the appropriate dosage of hemodialysis offered to patients, as well as the quality of filtration, based on the results of the percentage of urea reduction.

  pt-br

  Trata-se de um estudo prospectivo, transversal, analítico e descritivo, com abordagem qualitativa. O estudo foi realizado em um centro de terapia renal substitutiva. Foram constituídos 2 grupos, o primeiro grupo foi composto por 15 pacientes renais em terapia renal substitutiva. O segundo grupo foi composto por 09 pacientes renais em tratamento conservador. Os pacientes foram selecionados conforme critérios de inclusão. Ambos os grupos foram submetidos ao mesmo protocolo de Terapia com Luz de Baixa Intensidade, por meio de um colete de LED com 300 luzes (940 nm), os pacientes foram irradiados 15 minutos por dia, 3 vezes por semana, durante 60 dias. Antes dos pacientes iniciarem a Terapia com Luz de Baixa Intensidade, foram realizados exames de controle como hemograma completo, ureia, creatinina, potássio, cálcio, fósforo, ferro sérico, ferritina sérica, transferrina e TGP, com o objetivo de avaliar a dosagem adequada de hemodiálise oferecida aos pacientes, bem como, a qualidade da filtração, baseado nos resultados da porcentagem de redução de ureia

• Descriptors:

  en

  E02.594.540 Low Intensity Light Therapy

  pt-br

  E02.594.540 Terapia com Luz de Baixa Intensidade

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 01/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  24	-	25 Y	75 Y

• Inclusion criteria:

  en

  chronic kidney disease, male and female, age between 25 and 75 years, total number of patients 24

  pt-br

  doença renal crônica, sexo masculino e feminino, idade entre 25 a 75 anos, total de pacientes 24

• Exclusion criteria:

  en

  under 18 and over 80 years of age, debilitated, who do not sign the informed consent form

  pt-br

  idade inferior a 18 anos e superior a 80 anos, debilitados, que não assinarem o termo de consentimento livre esclarecido

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	N/A	N/A	N/A

Outcomes

• Primary outcomes:

  en

  The effect of photobiomodulation using infrared light-emitting diodes (LEDs) was evaluated in patients with chronic kidney disease undergoing dialysis and conservative treatment, in order to verify the improvement of renal function through urea and creatine biomarkers. The device used for photobiomodulation is called an LED vest and consists of an irradiation system consisting of a set of 300 LEDs (940nm). These are arranged in a grid-like distribution with a distance between them of 2 cm x 4 cm, positioned in the anterior region of the thorax and abdomen, through a vest measuring 36 x 5829 cm, with an area of ​​2088 cm². Characteristics of the LED system: total optical power of 6 W, power density of 2.9 mW/cm², and energy density of 2.6 J/cm². The total optical energy emitted during the 900s (15 minutes) of treatment was 5.4 kJ. The vest was applied 3 times a week for 60 days. A significant improvement was observed in the percentage of post-dialysis urea reduction, at the time of 60 days after photobiomodulation with LED, when comparing the treatment times between time zero (43.10±12.40) versus time 60 (34.30±12.30), where the value of p=0.0177, showing a statistically significant degree, p<0.05

  pt-br

  Foi avaliado o efeito da fotobiomodulação, empregando-se diodos emissores de luz (LEDs) infravermelho, em pacientes portadores de doença renal crônica em tratamento dialítico e tratamento conservador, afim de verificar a melhora da função renal, através de biomarcadores ureia e creatina. O dispositivo utilizado para a fotobiomodulação é denominado como um colete de LED, e consiste em um sistema de irradiação constituído por um conjunto de 300 LEDs (940nm). Estes são dispostos numa distribuição tipo rede com distância entre eles de 2 cm x 4 cm, posicionados na região anterior do tórax e abdome, através de um colete, tamanho de 36 x 5829 cm, com área de 2088 cm². Características do sistema de LEDs: potência óptica total de 6 W, densidade de potência de 2,9 mW/cm², e densidade de energia de 2,6 J/cm². A energia óptica total emitida durante os 900s (15 minutos) de tratamento foi de 5,4 kJ. O colete foi aplicado 3 vezes por semana durante 60 dias. Foi observado uma melhora significativa na porcentagem de redução da ureia pós diálise, no tempo de 60 dias após fotobiomodulação com LED, quando comparado os tempos de tratamento entre tempo zero (43,10±12,40) versos tempo 60 34,30±12,30), onde o valor de p=0,0177, mostrando estatisticamente um grau de significância, p<0,05

• Secondary outcomes:

  en

  No secondary outcomes are expected

  pt-br

  Não são esperados desfechos secundários

Summary Results

• Baseline char:

  en

   Group of patients undergoing dialysis treatment
  22 patients from the dialysis program of the HRBA nephrology department were included, literate, of both sexes, aged between 25 and 65 years, with a glomerular filtration rate (GFR) equal to or less than 15mL/min./1.73m² (stage 5-dialysis), and who agreed to participate in the research by signing the TCLE, in addition to the authorization of the person responsible for the hemodialysis department.  Group of patients undergoing conservative treatment
  The study included 10 chronic kidney patients undergoing conservative treatment, selected from the HRBA outpatient clinic, residing in Santarém, with outpatient follow-up by a nephrologist, literate, of both sexes, aged between 30 and 75 years, glomerular filtration rate (GFR) between 15 and 59 mL/min./1.73m² (stage 3 and 4 of chronic kidney disease) and stage 5 who were not undergoing hemodialysis and agreed to participate in the study by signing the TCLE.

• Participants flow:

  en

  dialysis treatment: 22 patients on dialysis, 07 excluded, 15 allocated.
  conservative treatment: 10 patients, 03 excluded, 07 allocated

• Adverse events:

  en

  There were no adverse events during the application of the protocol with LED vest

• Outcome measure:

  en

  Low Intensity Light Therapy at wavelength (940nm) applied through an LED vest with 300 lights, 15 minutes a day, 3 times a week for 60 days, in chronic renal patients undergoing renal replacement therapy and chronic renal patients undergoing conservative treatment, resulted in findings based on analysis of variance by ANOVA, where statistically significant results were observed that showed that the pre-dialysis urea index decreased over time, where the p-value = 0.0069, that is, the LED over time was able to significantly induce the reduction of urea, when comparing the means and standard deviation between the times, T0 (153.20 ± 38.34) vs T30 (126.80 ± 31.72), p < 0.05 and T0 (153.20 ± 38.34) vs T60 (122.60 ± 33.08), p<0.01. Post-dialysis urea also expressed significant values ​​in the reduction of its index, when comparing the treatment times between T0 (43.10±12.40) vs T60 34.30±12.30), where the p-value=0.0177, presenting a degree of statistical significance, p<0.05. It is worth highlighting that there is still no completed analysis of the variables of patients undergoing conservative treatment.

• Results summary:

  en

  This is a prospective, cross-sectional, analytical and descriptive study with a qualitative approach, which aims to evaluate the effects of photobiomodulation, using infrared light-emitting diodes (LEDs) in patients undergoing dialysis and conservative treatment, in order to verify the improvement of renal function through markers such as urea and creatine and other biochemical components such as complete blood count, potassium, calcium, phosphorus, serum iron, serum ferritin, transferrin, TGP and glomerular filtration rate.
  
  The study was carried out at the nephrology center of the Hospital Regional do Baixo Amazonas-HRBA. Two groups were formed: 1 group, renal patients undergoing dialysis treatment, where 22 patients were included in the study, 7 were excluded and 15 remained from the dialysis program of the HRBA nephrology sector, literate, both sexes, aged between 25 and 65 years, glomerular filtration rate (GFR) equal to or less than 15mL/min./1.73m² (stage 5-dialysis), and signed the TCLE. And the 2nd group, renal patients undergoing conservative treatment, where 10 patients were included in the research, 03 were excluded and 07 patients remained undergoing conservative treatment, selected at the HRBA outpatient clinic, residing in Santarém, with outpatient follow-up by the nephrologist, literate, both sexes, aged between 30 and 75 years, glomerular filtration rate (GFR) between 15 and 59 mL/min./1.73m² (stage 3 and 4 of chronic kidney disease) and stage 5 who are not undergoing hemodialysis and agree to participate in the research by signing the TCLE. The device used for data collection consisted of an irradiation system consisting of a set of 300 LEDs (940nm), arranged in a grid-type distribution with a distance between them of 2 cm x 4 cm, positioned in the anterior region of the thorax and abdomen, through a vest measuring 36 x 5829 cm, with an area of ​​2088 cm². Characteristics of the LED system: total optical power of 6 W, power density of 2.9 mW/cm², and energy density of 2.6 J/cm². The total optical energy emitted during the 900s of treatment was 5.4 kJ. Patients were irradiated for 15 minutes/day, 3 times/week, for 8 weeks. Data were processed and tabulated in Excel ® spreadsheets (Microsoft, USA) and statistically analyzed using the one-way ANOVA method. According to the laboratory results of the hematological components, the urea results showed that the pre-urea index showed a statistically significant decrease over time, where the p-value = 0.0069, that is, the LED over time was able to significantly induce a reduction in urea, when comparing the means and standard deviation between the times, T0 (153.20 ± 38.34) vs T30 (126.80 ± 31.72), p < 0.05 and T0 (153.20 ± 38.34) vs T60 (122.60 ± 33.08), p < 0.01. Post-dialysis urea also showed significant reductions in its index when comparing treatment times between T0 (43.10±12.40) vs T60 (34.30±12.30), where the p-value=0.0177, showing a statistically significant degree, p<0.05. On the other hand, when comparing post-dialysis urea between times T0 (43.10±12.40) vs T30 (38.10±13.60), it was observed that post-dialysis urea also showed a decrease in the averages, however, not in a statistically significant way, p>0.05.
  
  LED photobiomodulation did not imply the interruption of any therapeutic conduct performed by the patients, therefore, it showed a significant reduction in urea, which contributes to the improvement of the clinical condition of the patients, and may delay the progression of the disease.

Data Sharing Plan

• Data Sharing Plan:

  en

  No

Contacts

• Public contact
  • Full name: mariane santos ferreira
  • • Address: Av. Dr. Altino Bondesan, 500 – Distrito de Eugênio de Melo,
    • City: São José dos Camopus / Brazil
    • Zip code: 12247-016
  • Phone: +55 (93) 991842010
  • Email: mariane.lopess@hotmail.com
  • Affiliation: Universidade Anhembi Morumbi
   
• Scientific contact
  • Full name: mariane santos ferreira
  • • Address: Av. Dr. Altino Bondesan, 500 – Distrito de Eugênio de Melo,
    • City: São José dos Camopus / Brazil
    • Zip code: 12247-016
  • Phone: +55 (93) 991842010
  • Email: mariane.lopess@hotmail.com
  • Affiliation: Universidade Anhembi Morumbi
   
• Site contact
  • Full name: mariane santos ferreira
  • • Address: Av. Dr. Altino Bondesan, 500 – Distrito de Eugênio de Melo,
    • City: São José dos Camopus / Brazil
    • Zip code: 12247-016
  • Phone: +55 (93) 991842010
  • Email: mariane.lopess@hotmail.com
  • Affiliation: Universidade Anhembi Morumbi
   

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