Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic

• ClinicalTrials.gov Identifier: NCT03529097
• Recruitment Status: Withdrawn
• First Posted: May 18, 2018
• Last Update Posted: October 4, 2021
• Sponsor: Sheba Medical Center
• Information provided by (Responsible Party): Sheba Medical Center

Study Description

Brief Summary:

A randomised controlled trial to evaluate the role of IV fluids in renal colic.

Condition or disease	Intervention/treatment	Phase
Renal Colic	Drug: 0.9% Sodium-chloride; Drug: Placebos; Drug: Optalgin, Voltaren, Morphine	Phase 4

Detailed Description:

A RCT (Randomized Controlled Trial)to evaluate the role of 0.9% NACL (sodium chloride) IV fluids during an acute renal colic. The 2 arms will include -

1. 2 liters of 0.9% NACL IV fluids with pain killers
2. only pain killers The object is to find out if the IV fluids has any advantage in the care of renal colic. Does it helps to relive the pain? Does the stone eject earlier? Will there be fewer interventions?

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial to Evaluate the Efficiency of IV Fluids in the Treatment of Renal Colic
• Estimated Study Start Date: June 1, 2018
• Estimated Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Fluids; Intervention: 2 liters of 0.9% NaCl IV during the ER stay with pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not	Drug: 0.9% Sodium-chloride; 2 liters of 0.9% NaCl IV fluids; Drug: Optalgin, Voltaren, Morphine; Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.
Placebo Comparator: Placebo; No interventions, Only pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not	Drug: Placebos; 2 liters of 0.9% NaCl bag covered with black bag so the participant could not tell the fluids are not dripping to his vain; Drug: Optalgin, Voltaren, Morphine; Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.

Outcome Measures

Primary Outcome Measures :

1. Stone ejection without intervention [ Time Frame: 1 month ]
   Has the stone ejected without intervention? 1 month after the first visit in the ER (Emergency Room) we will preform an US or CT exam to verified that the stone ejected. If the stone that was seen by the US or CT in the ER is not present after 1 month we will assume it was spontaneously ejected. we would like to find out if there is any differences between the 2 groups in matter of spontaneously stone ejection. (Yes or No)
2. The need for urological intervention [ Time Frame: 0 to 1 month ]
   The need for urological intervention. 1 month after the visit in the ER we will check if the patient have gone through urological intervention such as urolithiasis. We would like to find out if there is any difference between the two groups in matter of urological intervention between 1 month after the visit in the ER. (Yes or No)
3. Pain [ Time Frame: 6 hours ]
   Measure the VAS (Visual Analogue pain Score). Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 6 hours of treatment in the ER

Secondary Outcome Measures :

1. Pain [ Time Frame: 1 Hour ]
   Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 hour of treatment in the ER
2. Pain [ Time Frame: 1 month ]
   Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 month from the first visit in the ER

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• above 18 years
• clinical renal colic
• a radiological proof (CT,US) to urolithiasis

Exclusion Criteria:

• below 18 years
• has a contraindication for IV fluids (such as CHF (Congestive Heart Failure)etc.)

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT03529097
• Other Study ID Numbers: SHEBA-18-4262-NK-CTIL
• First Posted: May 18, 2018
• Last Update Posted: October 4, 2021
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Colic; Renal Colic; Infant, Newborn, Diseases; Pain; Neurologic Manifestations; Dipyrone; Diclofenac; Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antipyretics