NCT01722630

Brief Summary

Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 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

March 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

November 2, 2012

Last Update Submit

November 5, 2012

Conditions

Intra Operative Fluid Management

Keywords

dopaminelaparoscopyfluid management

Outcome Measures

Primary Outcomes (1)

  • estimated glomerular filtration rate, tissue Doppler imaging, E/Ea

    EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.

    patients will be followed for the duration of surgery, an expected average of 3 hours

Secondary Outcomes (1)

  • total intra operative diuresis (TID)

    patients will be followed for the duration of surgery, an expected average of 3 hours

Study Arms (3)

control

NO INTERVENTION

Patients received intravenously saline solution at 5 ml/Kg/h

dopamine

EXPERIMENTAL

Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min

Drug: Dopamine

crystalloids

NO INTERVENTION

Patients received intravenously saline solution at 10 ml/Kg/h

Interventions

DopamineDRUG
Also known as: Revivan
dopamine

Eligibility Criteria

Age24 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I
  • age 24-42
  • patients undergoing gynaecological laparoscopy

You may not qualify if:

  • cardiovascular diseases
  • renal and endocrine disorders
  • obesity (BMI \> 30 Kg/m2)
  • the assumption of drugs that could interfere with renal parameters considered in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the sacred Heart

Rome, Rome, 00168, Italy

Location

MeSH Terms

Interventions

Dopamine

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 7, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

IT(1)