N/A
N=46
Restrictive Fluid Therapy in Severe Preeclampsia
Pre-Eclampsia
Bottom Line
View on ClinicalTrials.gov: NCT02214186 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy — 0.69; 0.73; 0.99; 0.93 mg/dl — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restrictive Fluid Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy |
0.69; 0.73; 0.99; 0.93; 0.96; 0.84 | <0.05 sig |
| PRIMARY Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index |
7; 6; 2; 4; 1; 0 | <0.05 sig |
| SECONDARY Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia |
0.16; 0.15; 0.18; 0.21; 0.15; 0.15 | <0.05 sig |
| SECONDARY Cystatin C as New Marker of Renal Injury in Preeclampsia |
1.73; 1.99; 1.93; 2.03; 1.64; 1.72 | <0.05 sig |
| SECONDARY Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration |
0.46; 2.62; 0.15; 0.40; 0.20; 0.45 | <0.05 sig |
| SECONDARY Platelets in Restrictive Fluid Management of Severe Preeclampsia |
194400; 207941; 183250; 201118; 192850; 221824 | >0.05 |
| SECONDARY International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section |
1.00; 0.95; 1.03; 0.95; 1.0; 0.95 | <0.05 sig |
| SECONDARY Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section |
0.98; 1.01; 1.07; 1.03; 1.07; 1.01 | <0.05 sig |
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.
Eligibility 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 ( 1 mg/dl
- previous kidney disease
- contraindication to spinal anesthesia
Data sourced from ClinicalTrials.gov (NCT02214186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.