Restrictive Fluid Therapy in Severe Preeclampsia

NCT02214186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-03-07

Study results available
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Summary

Introduction: Pre-eclampsia is a multifactorial syndrome which occurs in hypertension and proteinuria in pregnant women over 20 weeks gestation. It is the leading cause of maternal complications such as pulmonary edema, which occurs in about 3% of severe preeclamptic having as one of the causes volume overload. Anesthetic procedures are frequent in this population, with replacement with crystalloid of the duct during cesarean section under spinal anesthesia for combat hypotension and hypovolemia manifested by oliguria. However, as water therapy have antagonistic effects on cardiopulmonary and renal systems is no doubt as to the benefits compared to conventional or restrictive pattern of fluid therapy on renal function. Objective: To compare the renal function of patients with severe preeclampsia who received restrictive fluid therapy during caesarean section, as well as evaluating the use of cystatin C and Neutrophil gelatinase-associated lipocalin (NGAL) as a predictor of renal damage in this population. Hypothesis: Intraoperative fluid restriction did not influence renal function of patients with severe preeclampsia undergoing cesarean section under spinal anesthesia.

Conditions

  • Pre-Eclampsia

Interventions

OTHER

Restrictive Fluid Therapy

The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Wallace A Da Silva, MD · Hospital das Clínicas da Faculdade de Medicina da USP

  • Fernando Bliacheriene, PHD · Hospital das Clínicas da Faculdade de Medicina da USP

  • Maria José C Carmona, PHD · Hospital das Clínicas da Faculdade de Medicina da USP

  • Carlo Victor A Varela, MD · Hospital das Clínicas da Faculdade de Medicina da USP

  • Paula C Scherer, MD · Hospital das Clínicas da Faculdade de Medicina da USP

  • Marcelo Luis A Torres, PHD · Hospital das Clínicas da Faculdade de Medicina da USP

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02214186 on ClinicalTrials.gov