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Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache (PROPHYDRA)

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02859233
First received: July 21, 2016
Last updated: February 1, 2017
Last verified: February 2017
  Purpose

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.

The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.


Condition Intervention
Postdural Puncture Headache Other: Lack of hyperhydration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • The incidence of PDPH. [ Time Frame: At D5 ]
    PDPH will be observed on the 5th day (D5) after the lumbar puncture (D0). If PDPH is still present on the 5th day, the patient continues to be followed until the 8th day after the lumbar puncture

  • The incidence of PDPH (in case of PDPH still present at D5). [ Time Frame: At D8 ]
    PDPH will be observed also on the 8th day (D8) after the lumbar puncture (D0). , if PDPH was still present on the 5th day, to confirm the diagnosis of PDPH.


Secondary Outcome Measures:
  • The date of apparition of PDPH between day 0 and day 5 [ Time Frame: between day 0 and day 5 ]

Estimated Enrollment: 554
Actual Study Start Date: November 8, 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Routine advices about the interest of increase fluid after lumbar puncture to prevent PDPH will be transmitted: 2 liters will be provided to be drunk in 2 hours.
Experimental: Interventional group
Lack of hyperhydration : no particular advices will be transmitted about the interest of oral hyperhydration. 500 milliliters will be provided in case of thirst, according to patient's convenience.
Other: Lack of hyperhydration

Detailed Description:

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice by non-inferiority study, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the occurrence of PDPH in both of the two groups The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in need of dural puncture for diagnostic.
  • Age between 18 and 60 years old.
  • Patient willing to participate in the research.

Exclusion Criteria:

  • Pregnancy.
  • Contraindication for increased oral fluid intake.
  • Previous dural puncture within 5 day prior enrollment.
  • Parenteral fluid intake superior at 266 ml for 2 hours after dural puncture (1000 ml per day).
  • Enteral artificial feeding.
  • Patient not in capacity to understand correctly French.
  • Patient whose cannot be followed correctly by phone.
  • Patient refusing to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02859233

Contacts
Contact: Emmanuelle CARTRON +33 (0)240087528 emmanuelle.cartron@chu-nantes.fr

Locations
France
Hospital centre CHD VENDEE Recruiting
La Roche Sur Yon, France, 85925
Contact: Céline BALLET    + 33 (0)2 51 44 61 61    mailto:celine.ballet@chd-vendee.fr   
Principal Investigator: Céline BALLET         
Hospital centre LE MANS Recruiting
Le Mans, France, 72037
Contact: Marylène CATINAULT    +33 (0)2 44 71 08 86    mailto:mcatinault@ch-lemans.fr   
Principal Investigator: Marylène CATINAULT         
University Hospital NANTES Recruiting
Nantes, France, 44093
Contact: Emmanuelle CARTRON    +33 (0)253487528    emmanuelle.cartron@chu-nantes.fr   
Principal Investigator: Emmanuelle CARTRON         
Sub-Investigator: Jérémie ORAIN         
Hospital centre CORNOUAILLE Recruiting
Quimper, France, 29107
Contact: Marie-Annick QUEAU - LE HENAFF    + 33 (0)2 90 26 45 36    mailto:ma.queau@ch-cornouaille.fr   
Principal Investigator: Marie-Annick QUEAU - LE HENAFF         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Emmanuelle CARTRON Nantes University Hospital
  More Information

Publications:
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02859233     History of Changes
Other Study ID Numbers: RC16_0031
Study First Received: July 21, 2016
Last Updated: February 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nantes University Hospital:
Spinal Puncture
Dural puncture
Nursing

Additional relevant MeSH terms:
Headache
Wounds and Injuries
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017