NCT01486550

Brief Summary

The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

December 4, 2011

Last Update Submit

October 8, 2014

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

  • u-NGAL

    The main objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity

    2-4 hours

Secondary Outcomes (4)

  • u-Kim1 and u-LFABP

    2-4 hours

  • FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC

    2-4 hours

  • PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin

    2-4 hours

  • SBP, DBP, heartrate

    2-4 hours

Study Arms (2)

Voluven (Hydroxyethyl starch 130/0,4)

ACTIVE COMPARATOR

Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Drug: Voluven (Hydroxyethyl starch 130/0,4)

Sodium Chloride 9mg/ml

PLACEBO COMPARATOR

Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Drug: Sodium Chloride 9mg/ml

Interventions

Voluven (Hydroxyethyl starch 130/0,4)DRUG

7,5 ml/kg in the first hour and then 5 ml/kg minimum

Also known as: Voluven, Hydroxyethyl starch, Venofundin
Voluven (Hydroxyethyl starch 130/0,4)
Sodium Chloride 9mg/mlDRUG

7,5 ml/kg in the first hour and then 5 ml/kg

Also known as: Isotone saline solution
Sodium Chloride 9mg/ml

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Males and females
  • Indication for laparoscopic nephrectomy

You may not qualify if:

  • Blood donation within the last month
  • Lack of wish to participate
  • eGFR\< 15ml/min
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicinck forskningsafsnit, Regionshospitalet Holstebro

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

HES 130-0.4Hydroxyethyl Starch DerivativesSodium Chloride

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Anne Sophie P. Kancir, MD PhD

    Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2011

First Posted

December 6, 2011

Study Start

December 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DK(1)