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Trial record 3 of 44 for:    severe preeclampsia AND proteinuria

Restrictive Fluid Therapy in Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT02214186
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : September 7, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Other: Restrictive Fluid Therapy Not Applicable

Detailed Description:

Preeclampsia (PE) is the leading cause of morbidity and mortality worldwide during pregnancy. Fluid therapy for PE women during cesarean section is a controversial issue among medical specialists.

The replacement with crystalloid fluids tool is traditionally used by anesthesiologists during cesarean section under spinal anesthesia for combat hypotension and hypovolemia manifested by oliguria. However, as crystalloid infusion has antagonistic effects on cardiopulmonary and renal systems, there is controversy regarding benefits over conventional and restrictive fluid therapy. Therefore, due to cardiovascular changes in severe PE, restrictive fluid therapy could possibly be beneficial, avoiding complications such as acute pulmonary edema.

Currently, volume replacement during cesarean section in these patients is performed with volumes of about 1500 ml of crystalloid to decrease the chance of developing kidney injury or aggravating previous injury. However, it is not known in the literature whether the renal lesions that appear after birth in patients with PE are just due to the course of the disease itself or can be modified by fluid restriction during the conduct of anesthesia cesarean.

Moreover, intraoperative fluid restriction (250 ml crystalloid) appears as an alternative to handling the patient with PEG, as already safely used in cardiac patients, such as patients with mitral valve stenosis. The security of fluid restriction in patients with PE comes from the fact that pre-eclamptic suffer fewer episodes of hypotension during cesarean section under spinal anesthesia, requiring less fluid input for this purpose. In addition, the pathophysiology of this disease points to a relative hypovolemia, once the delivery performed, with removal of the placenta, fluids kidnapped in excess to third space (tissue edema) will be redirected to the intravascular compartment, restoring homeostasis.

Cystatin C and NGAL (Neutrophil gelatinase-associated lipocalin) arise as valid tools to predict the degree of renal injury. These molecules arise before the onset of renal injury, providing diagnostic and therapeutic actions that can reduce morbidity and mortality related to kidney failure, since some studies have shown that women in first pregnancy with PE are more likely to develop chronic kidney disease that pregnant women without PE.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Restrictive Fluid Therapy on Renal Function in Severe Preeclamptic Women Submitted to Cesarean Section Under Spinal Anesthesia
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 2015

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Arm Intervention/treatment
No Intervention: Liberal Fluid therapy
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
Active Comparator: Restrictive Fluid Therapy
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
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.




Primary Outcome Measures :
  1. Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy [ Time Frame: preoperative, first and second day postoperative ]
    Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.

  2. Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index [ Time Frame: Postoperative renal dysfunction ]
    Renal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150-200%, stage 2 200%-300%, and stage 3 more than 300% or hemodialysis


Secondary Outcome Measures :
  1. Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia [ Time Frame: preoperative, first and second day postoperative ]
    Evaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.

  2. Cystatin C as New Marker of Renal Injury in Preeclampsia [ Time Frame: preoperative, first and second day postoperative ]
    Evaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.

  3. Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration [ Time Frame: Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period ]
    Proteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.

  4. Platelets in Restrictive Fluid Management of Severe Preeclampsia [ Time Frame: preoperative, first and second day postoperative ]
    Compare platelets count in the restrictive and liberal groups during the first and second post-operative days.

  5. International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section [ Time Frame: preoperative, first and second day postoperative ]

    Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative.

    PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population.


  6. Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section [ Time Frame: preoperative, first and second day postoperative ]

    Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups.

    APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control.



Other Outcome Measures:
  1. Urine Output During Cesarean Section in Severe Pre-eclampsia [ Time Frame: urine output during cesarean section (an average of 60 minutes) ]
    Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe PE was defined as at least one of the following criteria: systolic pressure ≥160 mmHg or diastolic pressure ≥110 mmHg, severe proteinuria (>5 g/24 h), oliguria (<500 ml/24 h), cerebral or visual disturbances, pulmonary edema, epigastric pain, hepatic rupture, impaired liver function, thrombocytopenia, hemolysis, elevated liver enzymes and low platelet count (HELLP) syndrome and evidence of fetal compromise.

Exclusion Criteria:

  • previous serum creatinine levels >1 mg/dl
  • previous kidney disease
  • contraindication to spinal anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214186


Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, SP, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Wallace A Da Silva, MD Hospital das Clínicas da Faculdade de Medicina da USP
Study Chair: Fernando Bliacheriene, PHD Hospital das Clínicas da Faculdade de Medicina da USP
Study Director: Maria José C Carmona, PHD Hospital das Clínicas da Faculdade de Medicina da USP
Study Chair: Carlo Victor A Varela, MD Hospital das Clínicas da Faculdade de Medicina da USP
Study Chair: Paula C Scherer, MD Hospital das Clínicas da Faculdade de Medicina da USP
Study Director: Marcelo Luis A Torres, PHD Hospital das Clínicas da Faculdade de Medicina da USP

Publications:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02214186     History of Changes
Other Study ID Numbers: CAPPesq 675.011
First Posted: August 12, 2014    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: March 7, 2017
Last Verified: July 2014
Keywords provided by University of Sao Paulo General Hospital:
Pre-Eclampsia
Acute Kidney Injury
Fluid Therapy
Anesthesia, Spinal
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications