Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— SAFE-APD  

Official title:

The Study of Safety, Feasibility and Efficacy of Automated Peritoneal Dialysis in Acute Kidney Injury as Compared With Intermittent Hemodialysis, a Multi-center Non-blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598387
• Other study ID #: APD-AKI
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Peking Union Medical College Hospital
• Contact: Peng Xia, MD
• Phone: +86-13811684903
• Email: 7-xp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center randomized clinical trial study. The purpose of this study is to examine safety, feasibility and efficacy of automated peritoneal dialysis as compared with intermittent hemodialysis for AKI patients with indications for dialysis.

Description:

The incidence of acute kidney injury (AKI) is rapidly increasing worldwide. This is a common and devastating disorder, especially in critical illnesses, affecting 5-8% of all hospitalized patients and up to 30% of those in intensive care units, with high mortality. About 50-80% critical patients with AKI needed dialysis treatment. Intermittent hemodialysis (IHD) might be the most-commonly modalities applied in AKI patients requiring dialysis. However, no data of randomized study concerning renal recovery and treatment efficiency of AKI patients treated with APD is available in Chinese adult patients. This study is a 2-armed randomized controlled non-blind non-inferior trial to explore the feasibility, efficacy, and safety of APD in AKI patients as compared with intermittent hemodialysis. Base on the sample size estimation, 100 subjects (n=50 in each arm) should be enrolled in this study. The primary outcome is the rate of renal recovery (independence of dialysis) in the first 21days after initiation of renal replacement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• AKI patients according to Acute Kidney Injury Network criteria
• Rapidly rising serum creatinine level (a sudden increase of at least 30%)
• Meeting the indications for dialysis
• Uremia or azotemia (BUN>80 mg/dl)
• Fluid overload (after diuretics use)
• Electrolyte imbalance (K>5.5 mEq/L after clinical treatment)
• Acid-base disturbance (pH<7.2 and bicarbonate<10mEq/L after clinical treatment)

Exclusion Criteria:

• Age under 18 years, or older than 80 years
• Urinary tract obstruction; acute interstitial nephritis or rapidly progressive glomerulonephritis needed immunoinhibitory therapy
• Previously received renal replacement therapy(RRT) of any type/presence of dialysis access during the current illness.
• Pre-existing severe chronic kidney disease (baseline serum creatinine>4mg/dl) more than 10 days prior to initiation of first RRT.
• Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (<1month), multiple abdominal surgeries.
• Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure <80mmHg).
• Pregnant.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Automated peritoneal dialysis
The prescription of automated peritoneal dialysis: The first 48-72 hours dose: 0.8-2.0 liter exchange with 1-2 hour-cycle (8-36 liters per day); After initial 48-72 hours, 1.0-2.5L exchange with 2-6 hour-cycle (at least 8 liters per day), if the acidosis, hyperkalemia and pulmonary edema are corrected. The minimal target weekly Kt/V is 2.1-3.5/W.
• Intermittent hemodialysis
Intermittent hemodialysis will be performed 3-4h of each session and 2-5 times per week. The prescription will be adjusted based on patients' conditions to ensure spKT/V=1.3.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shannxi

Sponsors (6)

Lead Sponsor	Collaborator
Limeng Chen	Baxter Healthcare Corporation, Beijing Anzhen Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Hospital of China Medical University, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (2)

Gabriel DP, Caramori JT, Martim LC, Barretti P, Balbi AL. High volume peritoneal dialysis vs daily hemodialysis: a randomized, controlled trial in patients with acute kidney injury. Kidney Int Suppl. 2008 Apr;(108):S87-93. doi: 10.1038/sj.ki.5002608. — View Citation

Gabriel DP, Nascimento GV, Caramori JT, Martim LC, Barretti P, Balbi AL. Peritoneal dialysis in acute renal failure. Ren Fail. 2006;28(6):451-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of renal function recovery (independence of dialysis)	Patients do not require dialysis, urine output>1000ml/d and progressive drop in serum creatinine(<4mg/dl) and BUN(<50mg/dl).	At 21 days after the initiation of dialysis
Secondary	All-cause mortality within 21 days	The rate of all-cause of deaths at 21 days after the initiation of dialysis	At 21 days after the initiation of dialysis
Secondary	All-cause mortality within 90 days	The rate of all-cause of deaths at 90 days after the initiation of dialysis	At 90 days after the initiation of dialysis
Secondary	Access related complications within 21 days	Infections: peritonitis (APD), catheter-related infections (IHD); Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD); Exit site bleeding, pneumothorax, hernia	At 21 days after the initiation of dialysis
Secondary	Access related complications within 90 days	Infections: peritonitis (APD), catheter-related infections (IHD); Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD); Exit site bleeding, pneumothorax, hernia	At 90 days after the initiation of dialysis
Secondary	Dialysis related complications within 21 days	Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc	At 21 days after the initiation of dialysis
Secondary	The percentage of participants requiring termination of primary dialysis modality	Condtions leading to termination of primary dialysis modality, including bleeding, thromboebolism events, infections, access related complications and inadequate dialysis	At 90 days after the initiation of dialysis
Secondary	Length of stay in hospital	The time length of stay as an inpatient	From the time of admission to the time of discharge, up to 90 days
Secondary	Herth Hope Index within 21 days	Measure hope of patients using Herth Hope Index. Total possible points on the total scale is 48 points. The higher the score the higher the level of hope. To each question, strongly agree=4, agree=3, disagree=2, strongly disagree=1. Note: the scoring items need to be reversed scored in question 3 and 6.	At 21 days after the initiation of dialysis
Secondary	Health Status Questionnaire (Short Form-36) score within 21 days	Health Status Questionnaire (Short Form-36) is one of the most widely used generic measures of health-related quality of life and has been shown to discriminate between subjects with different chronic conditions and between subjects with different severity levels of the same disease.It generates 8 subscales and two summary scores. The 8 subscales are: physical functioning (Range 0-100), role limitations due to physical problems (Range 0-100), bodily pain (Range 0-100), general health perceptions (Range 0-100), vitality (Range 0-90), social functioning (Range 12.5-100), role-limitations due to emotional problems (Range 0-100), and mental health (Range 0-100). The two summary scores are the physical component summary (Range 13.6-61.9) and the mental component summary (Range 15.6-70.0). The higher the score is, the better quality of life of the patient is.	At 21 days after the initiation of dialysis
Secondary	Mini-Mental State Examination (MMSE) score within 21 days	The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. The maximum score is 30. The following three cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.	At 21 days after the initiation of dialysis
Secondary	Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days	Simplified Nutritional Appetite Questionnaire (SNAQ) ask the subject to complete answer 4 questions about the appetite. Tally the results based upon the following numerical scale: a=1, b=2, c=3, d=4, e=5. The sum of the scores for the individual items constitutes the SNAQ score. The maximum SNAQ score is 20. SNAQ score < 14 indicates significant risk of at least 5% weight loss within six months.	At 21 days after the initiation of dialysis