Back to resultsSafety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
Primary Purpose
Renal Insufficiency, Cis-Platinum Nephropathy
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
short hydration
conventional hydration
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring renal impairment, cisplatin, hydration protocol
Eligibility Criteria
Inclusion Criteria: Cancer patient who has plan to receive first cycle of cisplatin >= 60 mg/m2 Normal serum creatinine and creatinine clearance >= 50 ml/min Age < 75 years old Serum albumin >= 3 g/dl Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist Exclusion Criteria: The patient who receives other chemotherapy with adminstration volume higher than 500 ml Prior heart failure or known left ventricular ejection fraction > 50% Prior renal dysfunction within 3 months Uncontrolled renal disease current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months
Sites / Locations
- Faculty of Medicine Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
short hydration
conventional hydration
Arm Description
Normal saline (NSS) 500 ml infusion in 1 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 500 ml infusion in 1 hour, then NSS 500 ml infusion in 2 hours
NSS 1000 ml infusion in 8 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 2000 ml infusion in 16 hour
Outcomes
Primary Outcome Measures
renal dysfunction at least grade 1 following cisplatin treatment in short hydration group
increased serum creatinine of 0.3 mg/dl or serum creatinine >= 1.5-2x upper normal limit
Secondary Outcome Measures
renal dysfunction >= grade 2 following cisplatin treatment in short hydration group
serum creatinine > 2-3x upper normal limit
rate of cisplatin modification due to adverse effects in short hydration group
delay or dose reduction or discontinuation of cisplatin due to adverse effect
Full Information
NCT ID
NCT05884905
First Posted
April 30, 2023
Last Updated
May 23, 2023
Sponsor
Mahidol University
Collaborators
Siriraj Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05884905
Brief Title
Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
Official Title
Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
January 7, 2025 (Anticipated)
Study Completion Date
March 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Siriraj Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Cis-Platinum Nephropathy
Keywords
renal impairment, cisplatin, hydration protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
short hydration
Arm Type
Experimental
Arm Description
Normal saline (NSS) 500 ml infusion in 1 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 500 ml infusion in 1 hour, then NSS 500 ml infusion in 2 hours
Arm Title
conventional hydration
Arm Type
Other
Arm Description
NSS 1000 ml infusion in 8 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 2000 ml infusion in 16 hour
Intervention Type
Procedure
Intervention Name(s)
short hydration
Other Intervention Name(s)
short intravenous fluid infusion
Intervention Description
NSS infusion prior to and following cisplatin administration within 6 hours
Intervention Type
Procedure
Intervention Name(s)
conventional hydration
Other Intervention Name(s)
long intravenous fluid infusion
Intervention Description
NSS infusion prior to and following cisplatin administration over 24 hours
Primary Outcome Measure Information:
Title
renal dysfunction at least grade 1 following cisplatin treatment in short hydration group
Description
increased serum creatinine of 0.3 mg/dl or serum creatinine >= 1.5-2x upper normal limit
Time Frame
from starting cisplatin to 4-week after cisplatin discontinuation
Secondary Outcome Measure Information:
Title
renal dysfunction >= grade 2 following cisplatin treatment in short hydration group
Description
serum creatinine > 2-3x upper normal limit
Time Frame
from starting cisplatin to 4-week after cisplatin discontinuation
Title
rate of cisplatin modification due to adverse effects in short hydration group
Description
delay or dose reduction or discontinuation of cisplatin due to adverse effect
Time Frame
from starting cisplatin to 4-week after cisplatin discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cancer patient who has plan to receive first cycle of cisplatin >= 60 mg/m2
Normal serum creatinine and creatinine clearance >= 50 ml/min
Age < 75 years old
Serum albumin >= 3 g/dl
Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist
Exclusion Criteria:
The patient who receives other chemotherapy with adminstration volume higher than 500 ml
Prior heart failure or known left ventricular ejection fraction > 50%
Prior renal dysfunction within 3 months
Uncontrolled renal disease
current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suthinee Ithimakin, MD
Phone
+66898127440
Email
aesi105@yahoo.co.th
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10260
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suthinee Ithimakin
Phone
0898127440
Email
aesi105@yahoo.co.th
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
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