NCT00550186

Brief Summary

The purpose of this study is to assess the influence of different fluid infusions on the quantity of bladder retention after spinal anesthesia. This study should determine if this increase in bladder retention is significant and relevant.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

October 26, 2007

Last Update Submit

June 27, 2016

Conditions

DiuresisBladder Retention VolumeHypotension

Keywords

spinal anesthesiapreloaddiuresisbladder retention

Study Arms (3)

1

PLACEBO COMPARATOR

No preload

Other: placebo

2

ACTIVE COMPARATOR

Preload with cristalloid infusion

Drug: Ringers Lactate

3

ACTIVE COMPARATOR

Preload with collid infusion

Drug: HaemoHES 6%

Interventions

placeboOTHER
1
Ringers LactateDRUG
2
HaemoHES 6%DRUG
3

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA1-2
  • undergoing minor procedure under spinal anesthesia

You may not qualify if:

  • ASA3-4
  • History or signs of heart failure / coronary artery disease.
  • Bladder / urinary disease
  • Neurologic disease that may affect bladder function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Zevenaar

Zevenaar, Gelderland, Netherlands

Location

MeSH Terms

Conditions

HypotensionUrinary Retention

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Marco Peters, MD

    Nijmegen University Anesthesiology Department (resident)

    PRINCIPAL INVESTIGATOR

  • Ed Kamphuis, Md, PhD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2007

First Posted

October 29, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

NL(1)