Restrictive Fluid Therapy in Severe Preeclampsia
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| ClinicalTrials.gov Identifier: NCT02214186 |
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Recruitment Status :
Completed
First Posted : August 12, 2014
Results First Posted : September 7, 2015
Last Update Posted : March 7, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pre-Eclampsia | Other: Restrictive Fluid Therapy | Not Applicable |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Active Comparator: Restrictive Fluid Therapy
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
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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. |
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 |
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
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
| Brazil | |
| Hospital das Clínicas da Faculdade de Medicina da USP | |
| São Paulo, SP, Brazil, 01246903 | |
| 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier: | NCT02214186 |
| 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 |
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Pre-Eclampsia Acute Kidney Injury Fluid Therapy Anesthesia, Spinal |
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Eclampsia Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |