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Peritoneal Dialysis clinical trials

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NCT ID: NCT02811640 Completed - Peritoneal Dialysis Clinical Trials

Intra-abdominal Pressure in Peritoneal Dialysis Patients

Start date: June 30, 2016
Phase:
Study type: Observational

Patients treated with peritoneal dialysis (PD) are at increased risk of developing mechanical complications such as dialysate leaks and hernias thought to be related to an increase in intra-abdominal pressure (IAP) secondary to the addition of dialysate to the abdomen. Resistance training has been shown to increase IAP but it is unclear in the general population and in patients treated with PD if this training increases the risk of developing hernias. This study is observing the difference in IAP pressure measurements obtained by the Stryker intracompartmental (STIC) pressure monitor versus the standard IAP pressure measurements obtained with the insufflator at the time of PD catheter insertion.

NCT ID: NCT02593201 Completed - Peritoneal Dialysis Clinical Trials

The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels

Start date: February 26, 2016
Phase: Phase 4
Study type: Interventional

Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A recent study showed that an elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD effluent bacterial DNA fragment levels could prevent the development of relapsing and recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD peritonitis. After inform consent, they will be randomized to receive one additional week of the effective antibiotic treatment (the Preemptive Treatment Group) or no additional treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the completion of antibiotics for the measurement of bacterial DNA fragments. All patients will be followed for 6 months after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic treatment.

NCT ID: NCT02547103 Recruiting - Clinical trials for End Stage Renal Disease

Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection

COSMO-PD
Start date: June 1, 2016
Phase: Phase 4
Study type: Interventional

This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed up 24 months or completion of PD. The primary outcome is PD-related infection (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. Costs include providers and patients expenses. The utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipated nephrologists and health care professional involving to PD in decision-making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.

NCT ID: NCT02347592 Completed - Peritoneal Dialysis Clinical Trials

Peritoneal Dialysis Catheter Function

Start date: November 2007
Phase: N/A
Study type: Interventional

The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The investigators used these catheters in parallel for several years. To clarify what catheter has least problems the investigators performed a comparative study to clarify if outflow problems differed between these catheters.

NCT ID: NCT02270229 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua.

Start date: November 2014
Phase: N/A
Study type: Observational

The purpose of this study is to develop recommendations to assist in improving the current peritoneal dialysis (PD) program in a Hospital in Chinandega, Nicaragua. This project will consist of a needs assessment, a review of aggregate quantitative patient data from hospital records, and a knowledge, attitudes, and practices (KAP) assessment for medical providers, laboratory technicians, patients and primary caregivers. The final report will be used to obtain funding for the implementation of the recommendations.

NCT ID: NCT02168283 Withdrawn - Clinical trials for Chronic Kidney Disease

Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

Start date: December 2015
Phase: Phase 4
Study type: Interventional

INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease patients. However, cardiovascular disease remains the major cause of morbidity and mortality in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an important cause of cardiovascular disease in PD patients. OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood pressure, hospitalization and cardiovascular morbidity in PD patients. HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could improve the clinical outcome of PD patients. DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters. Patients will be randomized to active fluid management (treatment arm) or conventional management (control arm). STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy. INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling, diuretics, and intensive dialysis regimen. For the control arm, patients will only receive dietary counseling. Patients will be followed for one year. MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of hospitalization for all cause, and hospitalization for cardiovascular disease during the study period. DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization data will be compared by non-parametric Mann Whitney U test. EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload in PD patients.

NCT ID: NCT02128347 Completed - Peritoneal Dialysis Clinical Trials

Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients

Start date: October 2014
Phase: N/A
Study type: Interventional

Home dialysis has many potential benefits compared to in-center hemodialysis including improved quality of life, reduced hospital admission and reduced cost. However, some patients perceive that home modalities are associated with increased isolation from the healthcare system, substandard care or higher risk of catastrophic events. Providing better support for home dialysis patients may enhance their ability to maintain at home, improve their health outcomes, increase quality of life and improve satisfaction with care. In other chronic disease populations a secure, online communication portal between physicians and patients has proven useful in enhancing care for patients. Thus far, the utility of an online portal communication system has not been tested in a cohort of home dialysis patients. The investigators hypothesize that this novel form of communication will improve care and outcomes for home dialysis patients. Therefore, in a cohort of home dialysis patients, the purposes of this study are as follows: 1) Does an online patient-portal improve patient satisfaction with home dialysis care? 2) Does an online patient-portal improve quality of life? 3) Does an online patient-portal reduce hospitalization and health service utilization?

NCT ID: NCT01996930 Completed - Clinical trials for Chronic Renal Failure

Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites

STOP
Start date: December 2013
Phase: Phase 3
Study type: Interventional

Kidney failure is a devastating illness requiring treatment with dialysis or transplantation to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis (PD)or haemodialysis (HD). PD involves the placement of a soft, flexible plastic tube (catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the peritoneal cavity. This catheter exits from a hole in the abdomen and occasionally patients can have complications at this exit site. One possible complication is over-granulation. Over-granulation occurs as the wound attempts to heal and the skin around the exit site becomes red,'wet','bumpy' and stands 'proud' of the surrounding skin. An over-granulating exit site can lead to discomfort, pain, bleeding and harbour infection. More serious complications include dialysis failure, sepsis and death. There are several ways to treat over-granulation but there is limited research evidence to demonstrate which treatment is best. The study aims to compare current standard treatment which involves the application of silver nitrate by qualified nursing staff to chemically burn the tissue away, with an alternative treatment which involves the application of steroid impregnated tape to the area of over-granulating tissue by the patient themselves.

NCT ID: NCT01945203 Completed - Clinical trials for Cardiovascular Disease

The Relationship Between Aortic Pulse Wave, Aortic Calcification and Peripheral Artery Occlusion Disease in Peritoneal Dialysis Patients

Start date: December 2011
Phase: N/A
Study type: Observational

Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it. In recent years, there has been more and more recognition of a very high prevalence of CV calcification in the ESRD population. Many observational cohort studies have shown that CV calcification in these patients can predict mortality, CV mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may result in vessel calcification. Calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of CVD. Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. Thus, life safety and quality would be influenced severely and early detection might prevent future amputation. As compared with HD or pre-dialysis patients, uremic patients treated with PD have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in PD patients, are needed for future management and preventions of CV related morbidity and mortality.

NCT ID: NCT01852682 Completed - Hyperphosphatemia Clinical Trials

A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.