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Warming IV Fluids and Incidence of Hypotension

Primary Purpose

Assault by Hot Fluids

Status
Completed
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Active Comparator: Warming group
Sponsored by
Hakki Unlugenc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Assault by Hot Fluids

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria were previous cesarean delivery and breech presentation.

Exclusion Criteria:

  • Exclusion criteria included parturients younger than 18 and older than 43 years, significant coexisting disease such as preeclampsia or eclampsia, thyroid disorders, neurological disorders, increased risk of intra-operative hemorrhage (such as placenta accreta), and any contraindication to regional anaesthesia such as bleeding disorders or local infection.

Sites / Locations

  • Hakki Unlugenc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Warming group

Control group

Arm Description

Active Comparator: Warming group

Control group

Outcomes

Primary Outcome Measures

The primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section
Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg)

Secondary Outcome Measures

Secondary outcome measures were total volume consumption.
Total volume consumption (mL),
Secondary outcome measures were pain scores
Pain scores (VRS),
Secondary outcome measures were shivering and maternal and foetal side effects.
side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)

Full Information

First Posted
October 14, 2015
Last Updated
February 4, 2016
Sponsor
Hakki Unlugenc
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1. Study Identification

Unique Protocol Identification Number
NCT02582112
Brief Title
Warming IV Fluids and Incidence of Hypotension
Official Title
Do Warming iv Fluids During the Management of Spinal- Induced Hypotension Decrease the Incidence of Hypotension and Reduce the Requirement of Fluid, Blood and Ephedrine?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hakki Unlugenc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective, double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in cesarean delivery patients undergoing spinal anesthesia.
Detailed Description
Inadvertent perioperative hypothermia during cesarean delivery is not rare and frequently neglected, despite the recommendations by clinical guidelines. Exposure to cold air and infusing non-warmed intravenous (iv) fluids are the other main sources of inadvertent hypothermia. Spinal anesthesia used during the cesarean delivery has also been demonstrated to impair normal autonomic thermoregulatory control and extend inadvertent perioperative hypothermia. Various measures such as pre-warming of patients or fluids before anesthesia, peroperative warming of iv fluids and active/passive cutaneous warming techniques have all been used to prevent or to reduce inadvertent perioperative hypothermia. This prospective, double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in cesarean delivery patients undergoing spinal anesthesia. The hypothesis was that in elective caesarean delivery patients undergoing spinal anesthesia, warming intravenous fluids, would reduce the incidence of hypotension, ephedrine and transfusion requirement and volume consumption. Thus, the primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. Secondary outcome measures were total volume consumption, blood loss, pain scores, shivering and maternal and foetal side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assault by Hot Fluids

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warming group
Arm Type
Active Comparator
Arm Description
Active Comparator: Warming group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Active Comparator: Warming group
Intervention Description
Placebo Comparator: Control group
Primary Outcome Measure Information:
Title
The primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section
Description
Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary outcome measures were total volume consumption.
Description
Total volume consumption (mL),
Time Frame
6 months
Title
Secondary outcome measures were pain scores
Description
Pain scores (VRS),
Time Frame
6 months
Title
Secondary outcome measures were shivering and maternal and foetal side effects.
Description
side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria were previous cesarean delivery and breech presentation. Exclusion Criteria: Exclusion criteria included parturients younger than 18 and older than 43 years, significant coexisting disease such as preeclampsia or eclampsia, thyroid disorders, neurological disorders, increased risk of intra-operative hemorrhage (such as placenta accreta), and any contraindication to regional anaesthesia such as bleeding disorders or local infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakkı Ünlügenç, Prof Dr
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Hakki Unlugenc
City
Adana
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

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Warming IV Fluids and Incidence of Hypotension

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