Renal InsufficiencyNCT05884905
Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
A study testing short hydration and conventional hydration in people with Renal Insufficiency and Cis-Platinum Nephropathy, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency, Cis-Platinum Nephropathy
- What is being tested?
- short hydration and conventional hydration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 7 Mar 2023to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok, 10260
Suthinee Ithimakin, 0898127440, aesi105@yahoo.co.th
About this study
Official title: Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
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)
- Conditions
- Renal Insufficiency, Cis-Platinum Nephropathy
- Being tested
- short hydration, conventional hydration
- Keywords
- renal impairment, cisplatin, hydration protocol
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short hydrationProcedure or surgery
Also called short intravenous fluid infusion
NSS infusion prior to and following cisplatin administration within 6 hours
conventional hydrationProcedure or surgery
Also called long intravenous fluid infusion
NSS infusion prior to and following cisplatin administration over 24 hours
| Study group | Role | What they receive |
|---|---|---|
| short hydration | Experimental | 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 Receives: Procedure: short hydration |
| conventional hydration | Other | 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 Receives: Procedure: conventional hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from starting cisplatin to 4-week after cisplatin discontinuation
Secondary outcomes (2)
renal dysfunction >= grade 2 following cisplatin treatment in short hydration group
serum creatinine > 2-3x upper normal limit
Measured: from starting cisplatin to 4-week after cisplatin discontinuation
rate of cisplatin modification due to adverse effects in short hydration group
delay or dose reduction or discontinuation of cisplatin due to adverse effect
Measured: from starting cisplatin to 4-week after cisplatin discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start7 Mar 2023
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884905
- Sponsor's protocol ID
- si186/2023
- Status last verified
- May 2023
- First submitted
- 30 Apr 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jantarat A, Thamlikitkul L, Thephamongkhol K, Setakornnukul J, Phisalprapa P, Kositamongkol C, Srithongkul T, Ithimakin S. Efficacy and Safety of Short Intravenous Hydration for Preventing Nephrotoxicity From High-Dose Cisplatin: A Randomized, Open-Label, Phase II Trial. JCO Glob Oncol. 2025 Jan;11:e2400515. doi: 10.1200/GO-24-00515. Epub 2025 Jan 16.
PubMed 39819128
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
- ClinicalTrials.gov ID
- NCT05884905
- Acronym / sponsor ID
- si186/2023
- Conditions
- Renal Insufficiency, Cis-Platinum Nephropathy
- Keywords
- renal impairment, cisplatin, hydration protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short hydration | Experimental | Procedure: short hydrationNormal 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 |
| conventional hydration | Other | Procedure: conventional hydrationNSS 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short hydrationAlso: short intravenous fluid infusionNSS infusion prior to and following cisplatin administration within 6 hours | Procedure or surgery | short hydration |
| conventional hydrationAlso: long intravenous fluid infusionNSS infusion prior to and following cisplatin administration over 24 hours | Procedure or surgery | conventional hydration |
Primary outcome
renal dysfunction at least grade 1 following cisplatin treatment in short hydration group
Time frame: from starting cisplatin to 4-week after cisplatin discontinuation
increased serum creatinine of 0.3 mg/dl or serum creatinine >= 1.5-2x upper normal limit
2 secondary outcomes
renal dysfunction >= grade 2 following cisplatin treatment in short hydration group
Time frame: from starting cisplatin to 4-week after cisplatin discontinuation
rate of cisplatin modification due to adverse effects in short hydration group
Time frame: from starting cisplatin to 4-week after cisplatin discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 39819128Jantarat A, Thamlikitkul L, Thephamongkhol K, Setakornnukul J, Phisalprapa P, Kositamongkol C, Srithongkul T, Ithimakin S. Efficacy and Safety of Short Intravenous Hydration for Preventing Nephrotoxicity From High-Dose Cisplatin: A Randomized, Open-Label, Phase II Trial. JCO Glob Oncol. 2025 Jan;11:e2400515. doi: 10.1200/GO-24-00515. Epub 2025 Jan 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short hydration and conventional hydration in people with Renal Insufficiency and Cis-Platinum Nephropathy, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suthinee Ithimakin, MD (+66898127440, aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal dysfunction at least grade 1 following cisplatin treatment in short hydration group (time frame: from starting cisplatin to 4-week after cisplatin discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.