Warming IV Fluids and Incidence of Hypotension

Assault by Hot Fluids Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582112
• Other study ID #: HZLTNS98
• Status: Completed
• Phase: Phase 1
• First received: October 14, 2015
• Last updated: February 4, 2016
• Start date: September 2010
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Assault by Hot Fluids
• Hypotension

Intervention

Other:
• Active Comparator: Warming group
Placebo Comparator: Control group

Locations

Country	Name	City	State
Turkey	Hakki Unlugenc	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Hakki Unlugenc

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months	No
Secondary	Secondary outcome measures were total volume consumption.	Total volume consumption (mL),	6 months	No
Secondary	Secondary outcome measures were pain scores	Pain scores (VRS),	6 months	No
Secondary	Secondary outcome measures were shivering and maternal and foetal side effects.	side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)	6 months	No