NCT05884905

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

April 30, 2023

Last Update Submit

May 23, 2023

Conditions

Renal InsufficiencyCis-Platinum Nephropathy

Keywords

renal impairmentcisplatinhydration protocol

Outcome Measures

Primary Outcomes (1)

  • 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

    from starting cisplatin to 4-week after cisplatin discontinuation

Secondary Outcomes (2)

  • renal dysfunction >= grade 2 following cisplatin treatment in short hydration group

    from starting cisplatin to 4-week after cisplatin discontinuation

  • rate of cisplatin modification due to adverse effects in short hydration group

    from starting cisplatin to 4-week after cisplatin discontinuation

Study Arms (2)

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

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

Procedure: conventional hydration

Interventions

short hydrationPROCEDURE

NSS infusion prior to and following cisplatin administration within 6 hours

Also known as: short intravenous fluid infusion
short hydration
conventional hydrationPROCEDURE

NSS infusion prior to and following cisplatin administration over 24 hours

Also known as: long intravenous fluid infusion
conventional hydration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10260, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39819128DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Suthinee Ithimakin, MD

CONTACT

+66898127440aesi105@yahoo.co.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2023

First Posted

June 1, 2023

Study Start

March 7, 2023

Primary Completion

January 7, 2025

Study Completion

March 7, 2025

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)