Restrictive Fluid Therapy in Severe Preeclampsia

NCT02214186 | Completed Results DMC

• 1 other identifier: CAPPesq 675.011
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia; Acute Kidney Injury; Fluid Therapy; Anesthesia, Spinal

Outcome Measures

Primary Outcomes (2)

• Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy

  Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.

  preoperative, first and second day postoperative

• Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index

  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

  Postoperative renal dysfunction

Secondary Outcomes (6)

• Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia

  preoperative, first and second day postoperative

• Cystatin C as New Marker of Renal Injury in Preeclampsia

  preoperative, first and second day postoperative

• Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration

  Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period

• Platelets in Restrictive Fluid Management of Severe Preeclampsia

  preoperative, first and second day postoperative

• International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section

  preoperative, first and second day postoperative

Other Outcomes (1)

• Urine Output During Cesarean Section in Severe Pre-eclampsia

  urine output during cesarean section (an average of 60 minutes)

Study Arms (2)

Liberal Fluid therapy

NO INTERVENTION

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.

Restrictive Fluid Therapy

ACTIVE COMPARATOR

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Other: Restrictive Fluid Therapy

Interventions

Restrictive Fluid Therapy OTHER

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

Restrictive Fluid Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (14)

• Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.

  PMID: 15733721 BACKGROUND

• Sibai BM, Mabie WC. Hemodynamics of preeclampsia. Clin Perinatol. 1991 Dec;18(4):727-47.

  PMID: 1764880 BACKGROUND

• Aya AGM, Mangin R, Vialles N, Ferrer JM, Robert C, Ripart J, de La Coussaye JE. Patients with severe preeclampsia experience less hypotension during spinal anesthesia for elective cesarean delivery than healthy parturients: a prospective cohort comparison. Anesth Analg. 2003 Sep;97(3):867-872. doi: 10.1213/01.ANE.0000073610.23885.F2.

  PMID: 12933418 BACKGROUND

• Pan PH, D'Angelo R. Anesthetic and analgesic management of mitral stenosis during pregnancy. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):610-5. doi: 10.1016/j.rapm.2004.09.006. No abstract available.

  PMID: 15635522 BACKGROUND

• Dyer RA, Piercy JL, Reed AR, Lombard CJ, Schoeman LK, James MF. Hemodynamic changes associated with spinal anesthesia for cesarean delivery in severe preeclampsia. Anesthesiology. 2008 May;108(5):802-11. doi: 10.1097/01.anes.0000311153.84687.c7.

  PMID: 18431115 BACKGROUND

• Mabie WC, Ratts TE, Sibai BM. The central hemodynamics of severe preeclampsia. Am J Obstet Gynecol. 1989 Dec;161(6 Pt 1):1443-8. doi: 10.1016/0002-9378(89)90901-0.

  PMID: 2603896 BACKGROUND

• Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.

  PMID: 22420683 BACKGROUND

• Aya AG, Vialles N, Ripart J. [Anesthesia and preeclampsia]. Ann Fr Anesth Reanim. 2010 May;29(5):e141-7. doi: 10.1016/j.annfar.2010.03.014. Epub 2010 May 15. French.

  PMID: 20478690 BACKGROUND

• Urbschat A, Obermuller N, Haferkamp A. Biomarkers of kidney injury. Biomarkers. 2011 Jul;16 Suppl 1:S22-30. doi: 10.3109/1354750X.2011.587129.

  PMID: 21707441 BACKGROUND

• Vikse BE, Irgens LM, Leivestad T, Skjaerven R, Iversen BM. Preeclampsia and the risk of end-stage renal disease. N Engl J Med. 2008 Aug 21;359(8):800-9. doi: 10.1056/NEJMoa0706790.

  PMID: 18716297 BACKGROUND

• Xin C, Yulong X, Yu C, Changchun C, Feng Z, Xinwei M. Urine neutrophil gelatinase-associated lipocalin and interleukin-18 predict acute kidney injury after cardiac surgery. Ren Fail. 2008;30(9):904-13. doi: 10.1080/08860220802359089.

  PMID: 18925531 BACKGROUND

• Martensson J, Martling CR, Oldner A, Bell M. Impact of sepsis on levels of plasma cystatin C in AKI and non-AKI patients. Nephrol Dial Transplant. 2012 Feb;27(2):576-81. doi: 10.1093/ndt/gfr358. Epub 2011 Sep 12.

  PMID: 21765189 BACKGROUND

• Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.

  PMID: 17331245 BACKGROUND

• Silva WAD, Varela CVA, Pinheiro AM, Scherer PC, Francisco RPV, Torres MLA, Carmona MJC, Bliacheriene F, Andrade LC, Pelosi P, Malbouisson LMS. Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial. Clinics (Sao Paulo). 2020;75:e1797. doi: 10.6061/clinics/2020/e1797. Epub 2020 Jul 22.

  PMID: 32725073 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: M.D. Wallace Andrino da Silva
• Organization: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

wallaceandrino@yahoo.com.br

+551126616787

Study Officials

• Wallace A Da Silva, MD

  Hospital das Clínicas da Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

• Fernando Bliacheriene, PHD

  Hospital das Clínicas da Faculdade de Medicina da USP

  STUDY CHAIR

• Maria José C Carmona, PHD

  Hospital das Clínicas da Faculdade de Medicina da USP

  STUDY DIRECTOR

• 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 CHAIR

• Marcelo Luis A Torres, PHD

  Hospital das Clínicas da Faculdade de Medicina da USP

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: August 12, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 7, 2017
• Results First Posted: September 7, 2015

Record last verified: 2014-07

Locations

BR (1)