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

• ClinicalTrials.gov Identifier: NCT03451266
• Recruitment Status: Completed
• First Posted: March 1, 2018
• Last Update Posted: June 28, 2019
• Sponsor: University Medical Centre Ljubljana
• Information provided by (Responsible Party): Miha Lucovnik, University Medical Centre Ljubljana

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preeclampsia Severe; Preeclampsia Postpartum	Drug: Vitamin C; Drug: placebo	Phase 1

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia: a Randomized, Placebo-controlled Trial
• Actual Study Start Date: April 7, 2018
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: June 27, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin C; 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; 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.
Placebo Comparator: placebo; 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; 100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.

Outcome Measures

Primary Outcome Measures :

1. Echo Comet Score at day 1 post-delivery [ Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following 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.

Secondary Outcome Measures :

1. Echo Comet Score at day 2 post-delivery [ Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery ]
   One of the secondary outcomes studied will be the Echo Comet Score (ECS) at day 2 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.
2. Echo Comet Score at day 3 post-delivery [ Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery ]
   One of the secondary outcomes studied will be the Echo Comet Score (ECS) at day 3 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Locations

Slovenia

UMC Ljubljana

Ljubljana, Slovenia, 1000

Sponsors and Collaborators

University Medical Centre Ljubljana

  Study Documents (Full-Text)

Documents provided by Miha Lucovnik, University Medical Centre Ljubljana:

Study Protocol and Statistical Analysis Plan  [PDF] February 20, 2018

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Miha Lucovnik, Principal Investigator, Head of the Perinatal Intensive Medicine Unit, University Medical Centre Ljubljana
• ClinicalTrials.gov Identifier: NCT03451266 History of Changes
• Other Study ID Numbers: 2017 0031
• First Posted: March 1, 2018
• Last Update Posted: June 28, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miha Lucovnik, University Medical Centre Ljubljana:

preeclampsia; vitamin C; lung ultrasound

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Vitamins; Ascorbic Acid; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents