Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia

NCT03451266 | Completed Phase 1

• 1 other identifier: 2017 0031
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine whether administration of vitamin C (1.5g/6 hours) in the first three days post-partum reduces the amount of extravascular lung water assessed by lung ultrasound in patients with severe preeclampsia.

Conditions

Preeclampsia Severe; Preeclampsia Postpartum

Keywords

preeclampsia; vitamin C; lung ultrasound

Outcome Measures

Primary Outcomes (1)

• Echo Comet Score at day 1 post-delivery

  The primary outcome studied will be the Echo Comet Score (ECS) at day 1 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.

  Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following delivery

Secondary Outcomes (2)

• Echo Comet Score at day 2 post-delivery

  Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery

• Echo Comet Score at day 3 post-delivery

  Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery

Study Arms (2)

Vitamin C

EXPERIMENTAL

1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum (vitamin C arm).

Drug: Vitamin C

placebo

PLACEBO COMPARATOR

100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum (placebo arm).

Drug: placebo

Interventions

Vitamin C DRUG

1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.

Vitamin C

placebo DRUG

100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy with severe featutes of preeclampsia (any of the following):
• Systolic blood pressure of 160 mm Hg or higher, or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before this time)
• Thrombocytopenia (platelet count less than 100x109/L)
• Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (to twice normal concentration), severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnoses, or both
• Progressive renal insufficiency (serum creatinine concentration greater 97 µmol/L or a doubling of the serum creatinine concentration in the absence of other renal disease)
• Pulmonary edema
• New-onset cerebral or visual disturbances

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (6)

• Zieleskiewicz L, Contargyris C, Brun C, Touret M, Vellin A, Antonini F, Muller L, Bretelle F, Martin C, Leone M. Lung ultrasound predicts interstitial syndrome and hemodynamic profile in parturients with severe preeclampsia. Anesthesiology. 2014 Apr;120(4):906-14. doi: 10.1097/ALN.0000000000000102.

  PMID: 24694847 BACKGROUND

• Ambrozic J, Brzan Simenc G, Prokselj K, Tul N, Cvijic M, Lucovnik M. Lung and cardiac ultrasound for hemodynamic monitoring of patients with severe pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):104-109. doi: 10.1002/uog.17331. Epub 2016 Dec 1.

  PMID: 27736042 BACKGROUND

• Matsuda T, Tanaka H, Hanumadass M, Gayle R, Yuasa H, Abcarian H, Matsuda H, Reyes H. Effects of high-dose vitamin C administration on postburn microvascular fluid and protein flux. J Burn Care Rehabil. 1992 Sep-Oct;13(5):560-6. doi: 10.1097/00004630-199209000-00009.

  PMID: 1452590 BACKGROUND

• Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.

  PMID: 10722036 BACKGROUND

• Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.

  PMID: 27940189 BACKGROUND

• Korenc M, Zieleskiewicz L, Stopar Pintaric T, Blajic I, Ambrozic J, Lucovnik M. The effect of vitamin C on pulmonary oedema in patients with severe preeclampsia: A single-centre, randomised, placebo-controlled, double-blind trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100800. doi: 10.1016/j.accpm.2021.100800. Epub 2021 Jan 14.

  PMID: 33453456 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of the Perinatal Intensive Medicine Unit

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: March 1, 2018
• Study Start: April 7, 2018
• Primary Completion: June 25, 2019
• Study Completion: June 27, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)