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Colloid Preload Versus Colloid Coload During Cesarean Deliveries

Primary Purpose

Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)
hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)
Sponsored by
Sifa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia; Adverse Effect, Spinal and Epidural focused on measuring colloid preloading, colloid coloading

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Singleton pregnancy
  • Gestational age ≥ 37 weeks
  • Height ≥ 150 cm and ≤ 180 cm
  • Weight > 50 kg and < 100 kg

Exclusion Criteria:

  • Gestational age > 37 weeks
  • Multiple pregnancies
  • Fetal distress
  • Preeclampsia
  • Cardiovascular disease and diabetes
  • Hematological problems
  • Local infection at intervention site
  • Abnormal coagulation tests
  • Anticoagulant use
  • Starch allergy
  • Height < 150 cm and > 180 cm
  • Weight < 50 kg and > 100 kg

Sites / Locations

  • Şifa Üniversitesi, Basmane HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Preloading (Group P)

Group Coloading (Group C)

Arm Description

Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia.

Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible.

Outcomes

Primary Outcome Measures

Maternal hypotension.
Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.
Incidence of severe hypotension.
Incidence of severe hypotension (SAP < 70% of the baseline value or SAP < 80 mmHg) will be recorded.
Cumulative duration of hypotension.
Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).
Heart rate.
Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.

Secondary Outcome Measures

Neonatal effects.
Arterial and venous blood gas analyses will be performed from the umbilical cord after the cord clamped.
Ephedrine treatment.
If SAB < 100 mmHg; patients will be treated by 5 mg IV bolus ephedrine, if SAB < 90 mmHg; patients will be treated by 10 mg IV bolus ephedrine.
Nausea and/or vomiting.
Incidence of nausea and/or vomiting, incidence of prepartum nausea and/or vomiting will be recorded.

Full Information

First Posted
March 1, 2015
Last Updated
November 16, 2015
Sponsor
Sifa University
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1. Study Identification

Unique Protocol Identification Number
NCT02393196
Brief Title
Colloid Preload Versus Colloid Coload During Cesarean Deliveries
Official Title
Colloid Preload Versus Colloid Coload in Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Section Deliveries: A Prospective, Randomized, Double-Blind Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sifa University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Detailed Description
Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension
Keywords
colloid preloading, colloid coloading

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Preloading (Group P)
Arm Type
Active Comparator
Arm Description
Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia.
Arm Title
Group Coloading (Group C)
Arm Type
Active Comparator
Arm Description
Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible.
Intervention Type
Drug
Intervention Name(s)
hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)
Other Intervention Name(s)
(Voluven®; Fresenius Kabi, Bad Homburg, Germany)
Intervention Description
Before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)
Other Intervention Name(s)
(Voluven®; Fresenius Kabi, Bad Homburg, Germany)
Intervention Description
Just after spinal anesthesia
Primary Outcome Measure Information:
Title
Maternal hypotension.
Description
Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.
Time Frame
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Incidence of severe hypotension.
Description
Incidence of severe hypotension (SAP < 70% of the baseline value or SAP < 80 mmHg) will be recorded.
Time Frame
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Cumulative duration of hypotension.
Description
Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).
Time Frame
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Heart rate.
Description
Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.
Time Frame
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Secondary Outcome Measure Information:
Title
Neonatal effects.
Description
Arterial and venous blood gas analyses will be performed from the umbilical cord after the cord clamped.
Time Frame
Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Ephedrine treatment.
Description
If SAB < 100 mmHg; patients will be treated by 5 mg IV bolus ephedrine, if SAB < 90 mmHg; patients will be treated by 10 mg IV bolus ephedrine.
Time Frame
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Nausea and/or vomiting.
Description
Incidence of nausea and/or vomiting, incidence of prepartum nausea and/or vomiting will be recorded.
Time Frame
Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.
Other Pre-specified Outcome Measures:
Title
Preoperative fasting period.
Description
preoperative fasting period will be recorded.
Time Frame
Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Preoperative hemoglobin concentration (g/dL).
Description
Before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.
Time Frame
Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.
Title
Durations of anesthesia and surgery.
Description
Time period from induction of spinal anesthesia to skin incision (min), time period from induction of spinal anesthesia to delivery (min), time period from uterine incision to birth (sec), duration of anesthesia (min), and duration of surgery (min) will be recorded.
Time Frame
Time between induction of spinal anesthesia until end of the anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Singleton pregnancy Gestational age ≥ 37 weeks Height ≥ 150 cm and ≤ 180 cm Weight > 50 kg and < 100 kg Exclusion Criteria: Gestational age > 37 weeks Multiple pregnancies Fetal distress Preeclampsia Cardiovascular disease and diabetes Hematological problems Local infection at intervention site Abnormal coagulation tests Anticoagulant use Starch allergy Height < 150 cm and > 180 cm Weight < 50 kg and > 100 kg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysun Afife Kar, MD
Phone
+905326521313
Email
aaysunkar@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysun Afife Kar, MD
Organizational Affiliation
Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Şifa Üniversitesi, Basmane Hastanesi
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Colloid Preload Versus Colloid Coload During Cesarean Deliveries

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