Renal Function During Laparoscopic Surgery

November 5, 2012 updated by: Francesca Bevilacqua, Catholic University of the Sacred Heart

Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University of the Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Patients received intravenously saline solution at 5 ml/Kg/h
Experimental: dopamine
Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min
Drug: Dopamine
Other Names:
  • Revivan
No Intervention: crystalloids
Patients received intravenously saline solution at 10 ml/Kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estimated glomerular filtration rate, tissue Doppler imaging, E/Ea
Time Frame: patients will be followed for the duration of surgery, an expected average of 3 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
total intra operative diuresis (TID)
Time Frame: patients will be followed for the duration of surgery, an expected average of 3 hours
TID will be measured at the end of surgery
patients will be followed for the duration of surgery, an expected average of 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRF-2012-DH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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