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

Primary Purpose

Postdural Puncture Headache

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lack of hyperhydration
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postdural Puncture Headache focused on measuring Spinal Puncture, Dural puncture, Nursing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital centre CHD VENDEE
  • Hospital centre LE MANS
  • University Hospital NANTES
  • Hospital centre CORNOUAILLE

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Interventional group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The incidence of PDPH.
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).
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

Full Information

First Posted
July 21, 2016
Last Updated
August 22, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02859233
Brief Title
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache
Acronym
PROPHYDRA
Official Title
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
July 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache
Keywords
Spinal Puncture, Dural puncture, Nursing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lack of hyperhydration
Primary Outcome Measure Information:
Title
The incidence of PDPH.
Description
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
Time Frame
At D5
Title
The incidence of PDPH (in case of PDPH still present at D5).
Description
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.
Time Frame
At D8
Secondary Outcome Measure Information:
Title
The date of apparition of PDPH between day 0 and day 5
Time Frame
between day 0 and day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle CARTRON
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital centre CHD VENDEE
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hospital centre LE MANS
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
University Hospital NANTES
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hospital centre CORNOUAILLE
City
Quimper
ZIP/Postal Code
29107
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23771276
Citation
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
Results Reference
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PubMed Identifier
26950232
Citation
Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
Results Reference
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PubMed Identifier
16116106
Citation
Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
Results Reference
background
PubMed Identifier
3203698
Citation
Dieterich M, Brandt T. Incidence of post-lumbar puncture headache is independent of daily fluid intake. Eur Arch Psychiatry Neurol Sci. 1988;237(4):194-6. doi: 10.1007/BF00449906.
Results Reference
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Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache

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