NOVA COLLEGE OF PHARMACEUTICAL

EDUCATION AND RESEARCH INSTITUTE.

Jafferguda Village, Hayathnagar.

PHARM.D V – YEAR (2015-2021)

PROTOCOL

TITLE

MAINTENANCE OF COMPLICATIONS ASSOCIATED

WITH HAEMODIALYSIS.

STUDENTS: GUIDE:

U. SARASWATHI. (15CG1t008) Dr. NARESH SIR,

L. NARESH GOUD. (15CG1t004) ASSISTANT PROFESSOR
R. VANAJA. (15CG1t0015) DEPARTMENT OF PHARMACY.
A. ARPITHA. (15CG1t0001)

Principal sign HOD sign

Nova college of pharmacy
 PROTOCOL
1) Details:
a. Protocol title: MAINTENANCE OF COMPLICATIONS ASSOCIATED WITH
HAEMODIALYSIS.
b. Project Guide: Dr. Naresh Sir, Assistant Professor.
c. Name of the candidates: U. Saraswathi, L. Naresh Goud, R. Vanaja, A. Arpitha.
d. Institution: Nova College of Pharmaceutical Education and Research Institute.

2) Objectives:
a) Aims and objectives of the study:
AIM:
To study the maintenance of complications associated with haemodialysis.
OBJECTIVES:
1.Assessment of haemodialysis complications in CKD and ESRD patients.
2.Incidence of complications associated with haemodialysis in CKD and ESRD.
3.Management of haemodialysis complications.
4.Improving the quality of life in CKD, ESRD patients.

b) Introduction:

Hemodialysis was first successfully used in 1940, the procedure was not used widely
until Korean War in 1952. Permanent dialysis access was developed in the 1960’s which
allowed routine use of HD in patients with end stage renal disease. Subsequent decades
brought advances in dialysis technology, including the introduction of more efficient and
biocompatible dialyzer membrane and safer techniques. HD is now the most common types
of renal replacement therapy for patients with ESRD.

Hemodialysis: HD is a medical procedure, to remove fluid and waste products from the blood
and to correct electrolyte imbalances. This is accomplished using a machine and a dialyzer,
also referred to as an “artificial kidney”.

Principle of hemodialysis: Hemodialysis removes uremic toxins and excess fluid from the
blood by passive diffusion dialysis and ultrafiltration. The efficiency of this process depends
on the size, shape, and type of semipermeable membrane used in the hemodialyzer.
Common complications during HD include:

1) Haemodialysis Procedure Complications:

 Hypotension: predisposing factors such as hypovolemia and excessive ultrafiltration.,
antihypertensive medications prior to dialysis, low calcium and sodium in dialysis,
high dialysate temperature, meal ingestion prior to or during dialysis, diastolic
dysfunction, autonomic dysfunction.
 Hypertension: predisposing factors such as plasma sodium concentration,
intravascular volume, dialytic removal of antihypertensive medications, activation of
renin angiotensin aldosterone system.
 Cramps: predisposing factors such as muscle hypoperfusion due to ultrafiltration and
hypovolemia.
 Nausea and vomiting: predisposing factors such as hypotension.
 Headache: predisposing factors such as disequilibrium syndrome, caffeine withdrawal
due to dialysis removal.
 Pruritis: predisposing factors such as inadequate dialysis, skin dryness, secondary
hyperparathyroidism, abnormal skin concentrations of electrolytes, histamine release,
mast cell proliferation,
 Fever and chills: predisposing factors such as endotoxin release, infection of dialysis
catheter.
 Chest pain and back pain.
2) Vascular Access Complications:

Vascular access dysfunction is usually identified by a decrease in blood flow through

access over a period of days to week. Thrombosis and infection are the most common vascular
access complications with the highest occurrence in patients via a catheter. Infection is a
leading cause of mortality inn HD patients

Management of HD complications:

 Hypertension: the patient should be placed in the Trendelenburg position, and a

bolus of 0.9% saline should be rapidly administered through the blood time.
 Muscle cramps: Stretching exercise targeted at the affected muscle. Biotin 1mg per
day, quinine sulfate before dialysis.
 Nausea and vomiting: Pre dialysis dose of 5-10 mg metoclopramide.
  Headache: Acetaminophen can begin during dialysis
 Chest pain, back pain: managed by switching to different dialyzer membrane.
 Pruritis: usually antihistamine treatment.
 Infection and thrombosis: Fever developed during dialysis should be evaluated for
infections, antibiotics should be administered. To reduce catheter thrombosis,
catheter locking solutions with unfractioned heparin, recombinant tissue
plasminogen activator or sodium citrate instilled in each HD catheter lumen between
HD sessions.
c) Justification:

The life expectancy of dialysis patient is markedly lower than that of healthy
subjects of the same age and sex. In those older than 65years, the risk of mortality is 2 to 3-
fold higher in dialysis patients compared to those with diabetes, cancer, heart failure or
cardiovascular disease but not receiving dialysis. In addition to high morbidity and mortality,
a dialysis patient’s quality of life is generally poor. For example, restrictions caused by thrice
weekly hemodialysis and associated treatments have been shown to impact many areas of a
patient’s life. These include but are not limited to, physical exercise, employment, social life,
and diet. Patients often complain of fatigue and fear of the unknown related to their disease and
its progression. There is a need to assess the complications and management of complications
in dialysis patients in order to reduce mortality. This study focuses primarily on improving
quality of life in dialysis patients.

3. Literature survey:
1.Pharmacotherapy- a pathophysiologic approach 10th edition by joseph t. dipiro
 chapter 45 haemodialysis and peritoneal dialysis
 Kevin M. Sowinski, Marriann D. churchwell, and Brain S. Decker.

Because of limitation of available kidneys for transplantation, HD and PD remain the most
widely available and commonly used ESRD treatments.

2.KDIGO clinical practice guidelines for chronic kidney disease: 2013

Although the KDIGO guidelines published in 2013 now serve as general update to the
KDOQI guidelines, the 2006 version of KDOQI guidelines established recommendations
related to dialysis initiation.
3.Comorbidity and other factors associated with modality selection in incident dialysis
patients: the CHOICE Study. Choices for Healthy Outcomes in Caring for End-Stage
Renal Disease.

 Miskulin DC, et al. Am J Kidney Dis. 2002.

The increased survival of PD patients reported in recent studies may simply reflect the
self- or physician-directed selection of healthier patients to PD. Adjustment for case-mix
differences in patients treated with PD versus HD is essential to the assessment of the
independent effect of the dialysis modality on outcomes.

4.Complications during hemodialysis

 Sherman R, Daugirdas J: Handbook of dialysis. 5th edition.2014; 215-236

The book provides complete information on dialysis. The most common complications during
hemodialysis are in descending order of frequency: hypotension, cramps, nausea and vomiting,
headache, chest pain, backpain, and itching. Each complication management is thoroughly
described in the text.

5.Mortality benefits of different hemodialysis access types are age dependent.

 Hicks CW, et al. J Vasc Surg. 2015. Canner JK, Arhuidese l, Zarkowsky DS, Qazi
U, Reifsnyder T.

AVF is superior to AVG and HC regardless of the patient's age, including in

octogenarians. In contrast, the mortality benefit of AVG over HC may not apply to
younger (18-48 years) or older (>89 years) age groups. All patients 18 to 48 years
should receive AVF for dialysis access whenever possible.
6.Quinine for muscle cramps

 El-Tawil S, Al Musa T, Valli H, Lunn MP, El-Tawil T, Weber M.

There is moderate quality evidence that quinine significantly reduces cramp frequency,
intensity and cramp days in dosages between 200 and 500 mg/day. There is moderate quality
evidence that with use up to 60 days, the incidence of serious adverse events is not
significantly greater than for placebo in the identified trials. Further research is required on
the optimal dose and duration of use, and also alternative treatments.
7.Hemodialysis effect on platelet count and function and hemodialysis-associated
thrombocytopenia.

 Daugirdas JT, Bernardo A

Dialyzer hypersensitivity symptoms are infrequently associated with a fall in platelet

count. Most recent cases of dialysis-associated thrombocytopenia have been with polysulfone
membranes, especially polysulfone membranes sterilized by electron beam. The exact cause
of these reactions remains unknown.

8.Understanding the Complex Pathophysiology of Dyspnea in Chronic Kidney Disease.

 Salerno FR, Parraga G, McIntyre CW
Dyspnea is one of the most common symptoms associated with CKD. It has a
profound influence on the quality of life of CKD patients, and its underlying causes are
often associated with a negative prognosis. However, its pathophysiology is poorly
understood. While hemodialysis may address fluid overload, it often does not
significantly improve breathlessness, suggesting multiple and co-existing alternative
issues exist.
9.On the Importance of Pedal Edema in Hemodialysis Patients

 Rajiv Agarwal, Martin J. Andersen, and J. Howard P

Pedal Edema correlates with cardiovascular risk factors such as age, body mass index,
and left ventricular mass but does not reflect volume in hemodialysis patients.

10.Prevalence and causes of cough in chronic dialysis patients: a comparison between

hemodialysis and peritoneal dialysis patients.

 Min F, Tarlo SM, Poonam N, Richardson R

The findings suggest that GERD and associated cough are more common in PD
patients than in HD patients, perhaps owing to increases in intra-abdominal pressure from
the peritoneal dialysate.

4. Methodology:
Inclusion criteria:
1. 30 to 60 years patients who are receiving HD regularly.
2. CKD patient along with other comorbidities.
3. Patients with low GFR and high serum creatinine levels.
4. ESRD Patients.
5. Infected patients.
 Exclusion criteria:
1. Paediatric patients
2. Pregnant women.
3. Patients with acute renal failure.

5. Study design:

Literature survey

Development of protocol

Approval of Institutional Ethics Committee

Present study will be conducted in Gandhi hospital

Study will be conducted on maintenance of complications associated with hemodialysis.

Collection of data

Analysis of data

Effect of complications and maintenance in CKD, ESRD patients

Results

Statistical Analysis

Discussion

Conclusion
6. A schematic diagram of the study design, procedures and stages:
Literature Survey

Development of Protocol**

Approval of Ethics Committee

Data Collection and Monitoring

Analysis

Conclusion

Report
 7. Statistical justification for the number of Subjects to be included in the Study:

As the study being conducted for limited duration of 6 months and the number of subjects is
limited to 200-250.
8. Statistics:
Demographic Characteristics present in complaints, diagnosis, medication given prior to dialysis
changes made in drug therapy and discharge medication will be summarised using descriptive
statistics.
9. Finance and insurance: Academic study.
10. Publication policy: It is proposed to be sent for publication in Indian and international
journals with due acknowledgement of all the candidates, supervisors and institutions.
11. Glossary:
 CKD: It involves loss of kidney function over a period of months to years involving
kidney damage and glomerular filtration rate less than 60ml/min for 3months or
longer
 HEMODIALYSIS: HD is a medical procedure, to remove fluid and waste products
from the blood and to correct electrolyte imbalances. This is accomplished using a
machine and a dialyzer, also referred to as an “artificial kidney”.
 DIABETES: A disease in which the body’s ability to produce or respond to the
hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and
elevated levels of glucose in the blood.
 GLOMERULAR FILTRATION RATE: It estimates how much blood passes through
the glomeruli each minute. Glomeruli are the tiny filters in the kidneys that filter
waste from the blood.
 ESRD: End-stage renal disease is the final stage of chronic kidney disease. It means
the kidneys no longer function well enough to meet the needs of daily life. ESRD is
5th stage of progression of ckd.
 HYPOTENSION: Any blood pressure that is below the normal expected for an
individual in a given environment, less than 90/60mmhg.
 HYPERTENSION: Also known as high blood pressure (HBP), is a long-term
medical condition in which the blood pressure in the arteries is persistently elevated,
above 120/80mmhg.
 QOL: It is a subjective assessment of one's emotional and physical well-being.

12. List of abbreviations:

CRF: Chronic Renal Failure
ESRD: End Stage Renal Disease
GFR: Glomerular Filtration Rate
HD: Hemodialysis
KDQOL: Kidney Diseases Quality of Life
QOL: Quality of Life.
HTN: Hypertension.
 13. References:

1) Pharmacotherapy- a pathophysiologic approach 10th edition by joseph t. dipiro: chapter 45

haemodialysis and peritoneal dialysis Kevin M. Sowinski, Marriann D. churchwell, and Brain
S. Decker.
2) KDIGO clinical practice guidelines for chronic kidney disease: 2013
3) Comorbidity and other factors associated with modality selection in incident dialysis patients:
the CHOICE Study. Choices for Healthy Outcomes in Caring for End-Stage Renal Disease:
Miskulin DC, et al. Am J Kidney Dis. 2002.
4) Complications during hemodialysis: Sherman R, Daugirdas J: Handbook of dialysis. 5th
edition.2014; 215-236
5) Mortality benefits of different hemodialysis access types are age dependent: Hicks CW, et al.
J Vasc Surg. 2015. Canner JK, Arhuidese l, Zarkowsky DS, Qazi U, Reifsnyder T.
6) Quinine for muscle cramps: El-Tawil S, Al Musa T, Valli H, Lunn MP, El-Tawil T, Weber
M.
7) Hemodialysis effect on platelet count and function and hemodialysis-associated
thrombocytopenia: Daugirdas JT, Bernardo A
8) Understanding the Complex Pathophysiology of Dyspnea in Chronic Kidney Disease:
Salerno FR, Parraga G, McIntyre CW
9) On the Importance of Pedal Edema in Hemodialysis Patients: Rajiv Agarwal, Martin J.
Andersen, and J. Howard P
10) Prevalence and causes of cough in chronic dialysis patients: a comparison between
hemodialysis and peritoneal dialysis patients: Min F, Tarlo SM, Poonam N, Richardson R

Principal HOD of department

Nova College of pharmacy